Horizon Scanning for Drug Developments 2015/16 Based on the Prescribing Outlook Series 2015 The...

Horizon Scanning for Drug Developments 2015/16

Based on the Prescribing Outlook Series 2015

The information in this presentation is mainly relevant to items which will impact on prescribing in primary care.

IBD - moderate financial risk

IBD:

– No patent expiries on the horizon

– Various NICE guidance in 2015

– TA329 advises that consideration may be given to use of biosimilars and includes costing template.

– Two biosimilar infliximab products are available, it is estimated that £300,000 per 100,000 population was spent on infliximab in 14/15 (all indications). Assuming a 30% reduction in price and a 50% switch to use of biosimilar this could lead to savings of £45,000 per 100,000 population. (Some of these savings may have been realised since biosimilar infliximab was made available in Feb 2015).

Considerations for commissioners and providers:

• Demand management through service redesign may mean more patients are treated in primary care

• Agree local pathways for cytokine modulators recommended by NICE, include whether dose optimisation through antibody measurement and switching be supported

• Cytokine modulators e.g. TNF-inhibitors, are listed as exclusions in National Tariff 15/16, for indications outside NICE guidance a decision on funding will need to be agreed locally

New drugs of significant note - Gastrointestinal

• These additional agents have been identified within Prescribing Outlook New Medicines 2015 as being potentially significant in 2016/17:

• Obeticholic acid for primary biliary cirrhosis

• Additional information is available from Prescribing Outlook New Medicines 2015

Lipid modification - high financial risk

• NHSE medicines optimisation measurement work stream: low cost lipid modifying drugs and ezetimibe comparators have been retired. New comparator measures the number of items for bile acid sequestrants, fibrates, nicotinic acid and omega-3 fatty acid compounds as a % of total items.

• NICE guideline on lipid modification issued in July 2014: likely to have significant impact on CCG prescribing budgets for commissioners i.e. decreasing threshold for prescribing of statins is £120,000 per 100,000 population per year

• Rosuvastatin patent expires in Dec 2017. Continued work to replace rosuvastatin prescribing could save around £42,000 per 100,000 population although this would be off-set by atorvastatin prescribing.

• Unclear how updated draft of TA132 (ezetimibe for treatment of primary hypercholesterolemia) will impact prescribing budgets. However it is worth noting that the IMPROVE-IT trial is the first study to demonstrate that ezetimibe is associated with an improvement in clinical end-pints and may lead to an increase in use.

Lipid modification -high financial risk (cont’d)

• PCSK9 inhibitors: – Evolocumab licensed in UK in July 2015 for the treatment of primary hypercholesterolemia or

mixed dyslipidaemia in patients unable to reach LDL-C goals following maximum statin therapy or are statin intolerant. NICE guidance on evolocumab for treating primary hypercholesterolemia and mixed dyslipidaemia is expected in June 2016.

– Alirocumab is not yet marketed in the UK but was approved in the EU in September 2015. It will compete with evolucumab. NICE guidance on alirocumab is expected in June 2016.

– Cost of evolocumab 140mg/ml prefilled syringe = £170.10; cost per annum is £3642.60– Cost of alirocumab 75mg/ml and 150mg/ml prefilled syringe = £168; cost per annum is £4368– If it is assumed that all people who are not eligible for statin treatment receive a PCSK9 inhibitor

and that 10% of people who would be eligible for combination treatment with a statin receive a PCSK9 inhibitor rather than ezetimibe, this could result in an additional drug cost of about £165,000 per 100,000 per annum.

– CCGs will be responsible for commissioning for heterozygous familial hyperlipidaemia, non-familial and mixed hyperlipidaemia.

– NHSE responsible for commissioning homozygous familial hyperlipidaemia.

• Actions/issues: PCSK9 inhibitors likely to be National Tariff exclusions, therefore decision on funding for those indications outside NICE guidance will need to be agreed locally.

Heart failure – moderate to high financial risk

• Sacubitril valsartan (neprilysin inhibitor sacubitril + valsartan) – filed in EU in Feb 2015 for CHF.

• If observed beneficial effects on mortality and hospitalisation can be achieved in clinical practice, this fixed dose combination could displace current options.

• Likely to be more costly, increasing costs by an estimated £40,000 per 100,000 population. NICE guidance expected May 2016.

• Existing treatment pathways will need to be revisited once NICE guidance on sacubitril becomes available.

• NICE quality standards for acute heart failure and chronic heart failure expected in Dec 2015 and Feb 2016 respectively.

• Actions/issues: Many commissioners are redesigning services for HF to increase care provision via community HF clinics. Education and training requirements should be identified for practices and appropriate protocols should be developed for medicines optimisation.

New drugs of significant note - Cardiovascular


• Ticagrelor – license extension for stroke prevention Antidotes for NOACs


COPD – moderate financial risk

• Delivery of COPD service redesign in many areas to more care is commissioned in community, this could save £1.5 million per 100,000 population on COPD inpatient care alone.

• Smoking cessation has been demonstrated to be the most effective intervention for COPD and should be prioritized locally .

• Debate about the place in therapy and cost effectiveness of triple therapy (LABA+LAMA+ICS). The London Respiratory Team Value Pyramid highlights the high cost per QALY of triple therapy vs other treatment strategies.

• There are a number of combination inhalers now available (ICS/LABA and LABA/LAMA) – local guidelines should be developed on their place in therapy.

Licensed medicinal e-Cigarettes- high financial risk

• Licensed versions that will be prescribable as medicines may become available within the next 1-2 years (one is currently going through the licensing process and Voke – a nicotine inhaler but not a e-cigarette has been licensed but not launched).

• If a prescribable e-cigarette became available at a cost of £600 per year and is prescribed to 1 million people on an ongoing basis (about 40% of current e-cigarette users) – it would increase prescribing costs by £600m or about £1.1m per 100,000 population per year.

• There would be probably be some costs offset by reduced use of NRT but these are likely to be insignificant in comparison.

• This cost would double if just 15% of non-e-cigarette using tobacco smokers also converted to a prescribable e-cigarette to give a total cost of £2.2m per 100,000 population.

• Unlike current smoking cessation products e-cigarettes are aimed at reducing harm rather than facilitating nicotine withdrawal and are therefore potentially a life-long treatment.

House dust mite allergen immunotherapy

• Allergic rhinitis affects over 20% of the UK population, with about 20% uncontrolled on currently available pharmacotherapy (4,000 per 100,000).

• House dust mite allergen immunotherapy (HDM-AIT) would be used in selected patients in whom rigorous allergen avoidance and standard pharmacotherapy fail to control symptoms.

• Sublingual immunotherapy (SLIT) may be an attractive alternative to s.c immunotherapy, which is time-consuming and commonly associated with local adverse events, although treatment duration may be longer.

• It may reduce use of highly specialist allergy centres and expenditure on s.c immunotherapy.

• Cost calculator 2015 assumes 4,000 per 100,000 have allergic rhinitis and are being actively treated, and assume 5% are not adequately controlled and eligible for immunotherapy (200) assume annual cost ~£1,000 (based on 2010 cost of other immunotherapies) and predicts a cost of £200,000 per 100,000 population.

• Approved in 11 EU countries but not UK September 2015. UK availability anticipated 2016, it is expected to be tariff included.

Drugs of significant note in 2016/17 - CNS

• Prescribing Outlook notes Capsaicin patch - licence extension for peripheral neuropathic pain in adults with diabetes, as being potentially significant. Additional information is available from Prescribing Outlook New Medicines 2015

• Cost Calculator 2015 notes that if pregabalin generics become available with the full set of licensed indications, and this leads to a 70% decrease in the Drug Tariff cost for generic this would decrease prescribing costs by £317,000 per 100,000 population assuming that the NHS in England currently spends about £240m on this medicine.

Infections – patent expiries

• The following patent expiries which may have significant impact on prescribing costs are due in the next couple of years:

– Lopinavir/ritonavir (Dec 2015)

– Emtricitabine (Jan 2016)

– Linezolid (Jan 2016)

– Oseltamivir (Feb 2016)

– Telithromycin (Jul 2016)

– Voriconazole (Jul 2016)

– Adefovir dipivoxil (Sept 2016)

– Valganciclovir (Mar 2017)

– Caspofungin (Apr 2017)

– Entecavir (Apr 2017)

– Ertapenem (Apr 2017)

– Tigecycline (Aug 2017)

New drugs of significant note - Antimicrobial


• Inhaled antibacterial for patients with cystic fibrosis


Endocrine system – patent expiries

• The following patent expiries are due within the next few years:

– strontium ranelate (August 2015)

– Tolvaptan (Apr 2016)

– Dutasteride (Jul 2017)

– Insulin determir (Nov 2018)

Diabetes – high financial risk

• This is an area of major financial risk depending on the rate of uptake of newer therapies and the anticipated rise in the number of cases.

• Review of NICE guidance on the management of type 2 diabetes in adults published in Dec 2015. A resource impact is anticipated to come from a shift from sulphonylureas to more expensive DPP-4 inhibitors. Treatment with sulphonylureas is estimated to have an average cost of £84 per patient per year vs £431 for DPP-4 inhibitors. CCGs will need to monitor prescribing patterns accordingly.

• NICE guideline on the diagnosis and management of type 1 diabetes in adults was published in August 2015.

– The costing statement notes that there may be an increase in the use of insulin pump therapy, suggesting that this could be £10,000 per 100,000 population.

– The guideline recommends offering twice daily insulin determir as basal insulin therapy, this recommendation makes it difficult to promote the biosimilar version of insulin glargine to new patients and the difference in cost between the branded versions of determir and glargine is marginal.

• Potential savings from the availability of biosimilar insulin glargine: In 2014/15 the total spend on insulin glargine (Lantus®) in primary care in England was ~£70 million , a 50% switch to a biosimilar could result in savings of about £10,000 per 100,000 population.

Issues and Actions - Diabetes

• Actions/issues:

– Ensure local policy includes when to initiate but also when to stop newer agents.

– Consider development of guidance on appropriate use and choice of BGTS and meters.

– Commissioners and providers should work together to agree local key messages regarding the use of biosimilar insulin.

– Insulin pumps are Tariff excluded for 15/16 – local funding decisions need to be agreed.

Fertility – moderate financial risk

• Legal ruling relating to fertility guideline (May 2014)

The updated NICE CG gave stronger support for oocyte preservation. A court ruling determined that CCGs cannot choose not to follow NICE guidance just because

they do not agree with it.

• A biosimilar version of follitropin alfa (Ovaleap®) is expected to launch in 2015, which could represent cost savings (up to 30%)

• NICE have produced a support for commissioning for fertility problems tool

• Actions/issues: Commissioners and providers should agree on choice of gonadotrophin products locally. These drugs are tariff bundled.

MS – moderate financial risk

• Moderate financial risk because although NICE guidance has been in place for over 12 months, there may be incremental increases over a number of years.

• Actions/issues: Drugs for MS are listed as exclusions in the National Tariff 15/16. The responsible commissioner for MS drugs in England is NHSE.

• Local pathways may be needed to inform management of neuropathic pain and spasticity associated with MS.

Malignant Disease

• CDF – has been in place for over 4 years in England. Although the funds made available has increased from £200m to £280m per year, there has been significant delisting of products during 2015/16 to mitigate against a projected overspend. There has been a major revision of evidence to support the drugs currently funded to ensure that ongoing funding is justified. NHSE will work more closely with NICE to align their assessment processes moving into 2016/17.

• The Savings page from the 2015 UKMI Cost Calculator highlights possible savings associated with:

– Generic imatinib (expected early 2017): Data from the HSCIC indicates that approximately £82.3m (or ~£155,000 per 100,000 population) was spent on imatinib in 14/15 in the NHS. This spend is not separated out by indication. Assuming a 70% reduction in price and a complete switch to use of generic this could result in overall savings of around £109,000 per 100,000 population.

– Generic Pemetrexed (early 2016): Data from the HSCIC indicates that approximately £34m (or ~£64,000 per 100,000 population) was spent on pemetrexed in 14/15 in the NHS. This spend is not separated out by indication. Assuming a 70% reduction in price and a complete switch to use of generic this could result in overall savings of around £45,000 per 100,000 population.

– Biosimilar Rituximab (early 2017): Data from the HSCIC indicates that approximately £146m (or ~£275,000 per 100,000 population) was spent on rituximab in 14/15 in the NHS. This spend is not separated out by indication. Assuming a 30% reduction in price and a 50% switch to use of biosimilar this could result in overall savings of around £41,000 per 100,000 population.

Haematological cancers – moderate to high financial risk

• NICE guidance on

– Obinutuzumab in combination with chlorambucil for previously untreated CLL (June 2015)

– Ofatumumab for treating previously uncreated CLL(June 2015) - Within the costing statement NICE estimated that 550 patients in England will be eligible to receive wither this treatment of ofatumumab within 5 years and it will cost £6.8 million in England (about £14,000 per 100,000 population).

• Ofatumumab for maintenance treatment of relapsed CLL ( NICE expected September 2016): Ofatumumab may get licensed for this indication around mid-2016. There is an assumption that use of this drug for this indication could cost around £25,000 per 100,000 population.

• Idealisib for treating CLL (Oct 2015). Assumed costs of £25.000 to £49500 per 100,000 population. However no cost estimate from NICE as drug is NHSE commissioned and has a PAS scheme in place, which remains available via CDF until it moves to baseline funding.

• Ibrutinib for chronic CLL expected Jun 2016: likely to compete with Idealisib above.

• Carfilzomib for treating multiple myeloma in people who have received at least 1 prior therapy (expected Sept 2016): Assumed additional cost of £180,000 per 100,000 population.

• Lenalidomide for treatment of myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality (Sept 2014): Assumed expenditure of £20,000 per 100,000 population.

NHL and lymphomas – high financial risk

• NICE guidance:

– diagnosis and management of NHL (expected Aug 2016): expected to cover a wide range of issues but unlikely to impact significantly in terms of cost in the next financial year.

– Bendamustine in combination with rituximab for the first-line treatment of mantle cell lymphoma (date TBC): Assumed increase in current treatment costs of £6,600 per 100,000 population (currently available from CDF).

– Lenalidomide for treating relapse or refractory mantle cell lymphoma (expected June 2016): Anticipated to increase costs by about £21,500 per 100,000 population.

– Ibrutinib for treating relapsed or refractory mantle cell lymphoma (expected Dec 2016): Anticipated to increase costs by £50,000 per 100,000 population. If approved it is likely this drug will compete with lenalidomide for the same patient cohort.

– Bortezomib for untreated mantle cell lymphoma (expected Feb 2016): Anticipated to increase costs by around £7000 per 100,000 population.

– Brentuximab vedotin for treating people with CD30-positive Hodgkins's lymphoma after autologous stem cell transplant (expected Jul 2016): Anticipated additional costs of £8000 per 100,000 population (drug is currently available through the CDF)

Lung cancer – moderate financial risk

• NICE guidance:

– Ceritinib for previously treated anaplastic lymphoma kinase-positive NSCLC (expected Jan 2016): Anticipated increase in drug costs of around £14,000 per 100,000 population (currently available from CDF)

– Nintedanib for previously treated locally advanced, metastatic, or locally recurrent NSCLC (issued Jul 2015): Anticipated cost of £400 to £4600 per 100,000 population.

– Ramucirumab for treating metastatic NSCLC after platinum-based chemotherapy (expected Aug 2016): Anticipated increase in costs of £80,000 per 100,000 population. Although with level of survival gain expected, it is unlikely this will would meet NICE thresholds for cost effectiveness unless there is a substantial PAS discount.

Skin and connective tissue cancers – moderate to high financial risk

• NICE guidance:

– Dabrafenib and trametinib for treating advanced unresectable or metastatic BRAFV600 mutation-positive melanoma (expected Aug 2016). Anticipated increase in costs of about £5200 per 100,000 population.

– Ipilimumab for the adjuvant treatment of completely resected high risk stage III or IV melanoma (issue TBC). Assumed cost increases of about £102,000 per 100,000 population. BUT the manufacturer has not applied for a license yet, so unlikely to impact in the next financial year.

– Pembrolizumab for treating advanced melanoma after disease progression with ipilimumab (issued Oct 2015): Assumed cost increase of £16,000 per 100,000 population, although there is a commercial PAS scheme in place.

– Nivolumab with ipilimumab for untreated, advanced, unresectable, metastatic melanoma (expected Sept 2016): Anticipated cost increase of £43,000 per 100,000 population, although not clear when license extension is expected to be approved.

Ovarian cancer – moderate financial risk

• NICE guidance:

– Olaparib for the maintenance treatment of BRCA 1 or 2 mutated, relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer in people whose relapsed disease has responded to platinum-based chemotherapy (Jan 2016): Assumed cost increase of £29,000 per 100,000 population.

Prostate cancer – high financial risk

• Abiraterone acetate in combination with prednisolone for the treatment of metastatic castrate-resistant prostate cancer in people who have not been previously treated with chemotherapy. Anticipated increase in costs £225,000 per 100,000 population, in the FAD NICE do not support the use of abiraterone for this indication on the ground pf cost-effectiveness, the drug is available via CDF.

• Degarelix depot for treating advanced hormone dependent prostate cancer (issue date TBC): Anticipated cost increase £600 to £4200 per 100,000 population in year 1, rising to between £3,600 and £25,000 per 100,000 at steady state. But awaiting NICE re-evaluation.

• Radium 223 dichloride for treating metastatic hormone relapsed cancer with bine metastases (expected Jan 2016): If it is used in addition to abiaterone there would be an anticipated cost increase of £36,000 per 100,000 population. Previously available through CDF, this indication is subject to an appeal outcome.

• Enzalutamide for treating metastatic hormone-relapsed prostate cancer not previously treated with chemotherapy (issue date TBC): Will compete with abiaterone for this indication and is currently available via the CDF.

• Cabazitaxel for hormone-relapsed metastatic prostate cancer previously treated with a docetaxel-containing regimen (review of TA255) (Due May 2016): Anticipated cost increase of £44,000 per 100,000 population, currently available via CDF.

Rheumatology – moderate financial risk

• NICE CG Rheumatoid Arthritis – update (expected Dec 2015): The recommendations on pharmacological management of RA do not appear to have changed in the update.

• Biologics: As usage is likely to be a substitution of one agent for another, it is unlikely there will be a significant impact on spend in this area (as long as NICE criteria for starting and stopping the drug is followed).

• If NICE support earlier use of biologics there could be some additional cost impact.

• Organisations should agree which agents should be preferred based on locally agreed discounts. The service delivery costs of IV administered agents should also be considered alongside the savings achievable through the use of biosimilars.

Psoriatic arthritis – low to moderate financial risk

• NICE guidance on:

– Ustekinumab for treating active psoriatic arthritis (issued June 2015): Not expected to have a significant impact on NHS resources.

– Apremilast for treating active PsA (issue date TBC): FAD does not recommend use, however is under appeal and if appeal is upheld and changes follow there could be a possible additional cost impact of between £3500 to £11,000 per 100,000 population (based on list price).

• Savings through the use of biosimilar versions of infliximab and etanercept.

• Estimates of savings of around £45,000 per 100,000 population from infliximab biosimilar, although some of these savings may have already been realized.

• For etanercept savings could be around £102K per 100,000 population, a biosimilar version is due to be launched in Q4 15/16.

Issues/ actions for Musculoskeletal and joint diseases

• Cytokine modulators e.g. TNF-inhibitors and apremilast are tariff excluded 15/16. A decision on funding will need to be agreed locally for these for indications outside NICE recommendations.

• Several biologics have been approved by NICE for the treatment of RA. Commissioners and providers should locally agree a treatment pathway in these patients, including preferred choices for 1st and sequential line use. Similarly, locally agree treatment pathway for JIA (in particular when patients transfer between commissioners from child to adult services), AS and PsA including use of biologic agents.

• Some organisations have included the use of sub-cutaneous methotrexate prior to progressing to biologics in their treatment pathways as this step could delay the need for cytokine modulators in some patients and therefore reduce costs.

• Locally agree principles for the use of biosimilar versions of infliximab and etanercept, including whether switching existing patients will be supported and whether any time limited gain share arrangements will be implemented.

• Commissioners may wish to refer to the commissioning guide produced by NICE for the use of biologic drugs for the treatment of inflammatory disease in rheumatology, dermatology and gastroenterology to aid these decisions. NICE has also produced a guide for Support for Commissioning for RA

• Trusts should audit this area of prescribing to ensure that any variations to the drug regimens recommended in the NICE guidance are appropriate.

New drugs of significant note - Musculoskeletal


• Tofacitinib (oral) for Rheumatoid Arthritis


SLE – moderate financial risk

• NICE guidance on use of Belimumab for the treatment of active autoantibody-positive SLE (Issue TBC): Launched in UK in September 2011, but NICE FAD in 2012 and again in 2013 did not recommend belimumab as per licensed indication. Further evidence along with a patient access scheme have been resubmitted to NICE. It has been anticipated that the total cost implication for belimumab in SLE could result in additional costs of ~£63,500 per 100,000 population per year (drug cost only excl. VAT, details of the PAS are unknown).

• Actions/issues:

– Belimumab is listed as exclusion in the National Tariff for 15/16. NHS England is the responsible commissioner for this drug. Drug exclusions under Payment by Results 15/16.

– NHS England has set out criteria for use of rituximab in SLE in an interim policy

Spasticity – moderate financial risk

• NICE guidance:

– The use of collagenase clostridium histolyticum for treating Dupuytren's contracture, expected date TBC: NICE FAD under appeal, if upheld there could be an increased cost impact of £9,360 per 100,000 population (drug cost only)

– Botulinum toxin type A for treating upper or lower limb focal spasticity associated with stroke (issue date TBC). This guidance is not expected to impact in 16/17

Macular oedema – high financial risk

• NICE guidance:

– The use of Aflibercept for the treatment of DMO (TA346) (issued Jul 2015): Estimated cost impact: £48,407 per 100,000 over and above the current expenditure on ranibizumab in this population.

• Dexamethasone intravitreal implant for DMO (issued Jul 2015): The annual total cost of implementing this guidance for the incident population is estimated at a cost of £7,845per 100,000 population per annum, assuming unilateral treatment. The costing report also suggests that there will be a non-recurring cost for treating the prevalent population not previously treated with fluocinolone, estimated to be implemented over 3 years at a cost of £17 million in year 1 (which equates to ~£32,000 per 100,000 population, £17 million in year 2 and £15 million in year 3.

• Aflibercept for visual impairment due to macular odeoma secondary to branch retinal vein occlusion (due Oct 2016): No information on impact is currently available, but SMC figures suggest that net budget impact could be around £6000 per 100,000 population in year 1 and £11,730 in year 5 (based on list prices of aflibercept and ranibizumab).

• Actions/issues:

– Locally agree pathways for various ophthalmology indications.

– Many of these agents are listed as exclusions in the National Tariff for 15/16. A decision on funding will need to be agreed locally for these agents for indications outside NICE guidance.

Ophthalmology – high financial risk

• Actions/issues:

– Locally agree pathways for various ophthalmology indications.

– Commissioners may wish to refer to the commissioning guide produced by NICE on commissioning a service for people at risk of developing glaucoma.

– Commissioners and providers should review the ophthalmology specials list developed by the Royal College of Ophthalmologists and agree on a local formulary for these agents based on this guidance. The list was recently updated (June 2015).

Skin

• Significant patent expiries are due within the next couple of years: alitretinoin (Oct 2015); pimecrolimus (Nov 2015)

• NICE guidance:

– apremilast for moderate to severe plaque psoriasis, (Nov 2015): not recommended by NICE

– secukinumab for moderate to severe plaque psoriasis, issued Jul 2015: Expert clinical opinion estimates uptake may be up to 20% of the eligible population (7 per 100,000 which equates to cost of ~£64,000 per 100,000 when used as first line biological). In this scenario, the costing template assumes that secukinumab is cost neutral. However if secukinumab is used as a second or third line biological following failure of TNFi(s), this could result in an additional cost of ~ £82,300 per 100,000

• Savings through the use of biosimilar versions of infliximab and etanercept: For infliximab, assuming a 30% reduction in price and a 50% switch to use of biosimilar, this could result in overall savings of around £45,000 per 100,000 population. Some of these savings may have already been realised as biosimilar infliximab has been available since February 2015.

• For etanercept, assuming a 30% reduction in price and an 80% switch to the biosimilar, this could release overall savings of around £102K per 100,000 population. A biosimilar version of etanercept is due to be launched in Q4 15/16.

• Actions/issues:

– A decision on funding will need to be agreed locally for these for indications outside NICE recommendations.

– Several biologics have been approved by NICE for the treatment of psoriasis. Commissioners and providers should locally agree a treatment pathway in these patients, including preferred choices for 1st line and sequential line use.

Urticaria

• NICE guidance on omalizumab for previously treated chronic spontaneous urticaria, issued Jul 2015: CCG commissioned, the estimated cost of implementing the guidance is ~£38,000 per 100,000. (Without inclusion of PAS). The additional population receiving omalizumab is estimated to be 7 per 100,000 per year from year 5 following implementation.

• NICE guidance on adalimumab for treating moderate to severe hidradenitis suppurativa, expected Jun 2016: Anticipated additional drug cost ~£288,000 per 100,000

• Actions/issues: Adalimumab is listed as an exclusion in the National Tariff for 15/16. A decision on funding will need to be agreed locally for this indication outside NICE recommendations. NHSE is the responsible commissioner for adalimumab, however omalizumab is CCG commissioned.

Issues and Actions - Skin

Actions/issues:

–Demand management through service redesign may mean more patients are treated in primary care for simple dermatological conditions using condition specific protocols instead of being referred to secondary care.

–Locally agree principles for the use of biosimilar versions of infliximab and etanercept, including whether switching existing patients will be supported and whether any time limited gain share arrangements will be implemented.

–Review use of wound care products locally and develop local guidelines, including community nursing services. This has the potential for releasing savings through a reduction in the inappropriate use of dressings, such as silver dressings.

–Commissioners and providers should jointly review the updated BAD specials list and agree which areas should be included within local formularies.

New drugs of significant note - Skin


• Tofacitinib (oral) for Psoriasis


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