Pricing Reimbursment and Market Acces Issue #19
Institute for Clinical and Economic Review releases revised evidence report on dupilumab and crisaborole for treatment of atopic dermatitis
12 May 2017 — Limitations noted on the evidence for crisaborole; analyses find stronger evidence for dupilumab and suggest its price has been set to align fairly with its added benefit for patients. The Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of dupilumab and crisaborole for the treatment of atopic dermatitis. This evidence report will be the subject of the upcoming public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) on 25 May 2017.The report evaluates the evidence on dupilumab (Dupixent, Sanofi-Regeneron), an injectable treatment for moderate-to-severe atopic dermatitis, and crisaborole (Eucrisa, Pfizer), a topical treatment for mild-to-moderate atopic dermatitis, focusing on the clinical benefits, side effects, and value of these therapies compared to other treatment options available.
Oncolytics Biotech announces FDA fast track designation for Reolysin in metastatic breast cancer
8 May 2017 — Oncolytics Biotech announced that the United States FDA has granted fast track designation for Reolysin, the company’s proprietary immuno-oncology viral agent, for the treatment of metastatic breast cancer.
WHO wants transparency, market revamp for fairer drug pricing
11 May 2017 — The world needs greater transparency on the pricing of medicines, and an overhaul of some approaches, in order to increase access to life-saving drugs, global health experts said on Thursday.
Drug makers are under growing fire as a wave of new treatments for serious conditions like cancer and hepatitis C come to market at sky-high prices, putting them out of reach of many patients and national health services.
“The problem has become global,” said Suzanne Hill, head of essential medicines at the World Health Organisation.
Proteon Therapeutics receives FDA breakthrough therapy designation for vonapanitase
10 May 2017 — Proteon Therapeutics announced that its investigational treatment, vonapanitase, has received breakthrough therapy designation from the U.S. FDA for increasing arteriovenous fistula secondary patency (i.e., survival of the fistula without abandonment) and use for haemodialysis in patients on or expected to initiate haemodialysis.
Rhythm receives expanded FDA breakthrough therapy designation for setmelanotide for rare genetic disorders of obesity
11 May 2017 — Rhythm has announced that the U.S. FDA has expanded a previously granted breakthrough therapy designation for setmelanotide, the company’s novel melanocortin-4 receptor agonist. The expanded breakthrough therapy designation is for the treatment of obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway (the MC4 pathway), which includes both pro-opiomelanocortin (POMC) and leptin receptor (LepR) deficiency obesity.
The FDA had previously granted BTD to setmelanotide for the treatment of POMC deficiency obesity.
NICE publishes second appraisal consultation document for venetoclax
1 May 2017 — The first appraisal consultation in February 2017 recommended against the use of venetoclax on the NHS.
The news for AbbVie is not good; the second appraisal consultation document does not support the use of venetoclax.
European Commission grants approval for Merck’s new Pergoveris pen for fertility treatment
10 May 2017 — With this approval, Pergoveris becomes the first product with a combination of FSH and LH hormones in a ready-to-use liquid version.
Merck today announced that the European Commission has granted approval for the new Pergoveris Pen, addressing an unmet medical need by providing an improved, convenient and ready-to-use fertility combination treatment option for women with severe follicle stimulating hormone and luteinizing hormone deficiency.
European Commission approves the only immunotherapy for high-risk neuroblastoma, bringing hope to thousands of children affected by a rare and devastating form of cancer
9 May 2017 — EUSA Pharma today announced that the European Commission has approved the antibody ch14.18/CHO, dinutuximab beta, for the treatment of high-risk neuroblastoma in patients aged 12 months and above.
Today’s announcement makes dinutixumab beta the only approved immunotherapy in Europe for high risk neuroblastoma and an important tool in the fight against the condition.
Institute for Clinical and Economic Review posts briefing paper on assessing the value of drugs for rare conditions
10 May 2017 — Report contains a technical brief on Spinraza and will inform discussions at ICER pricing summit on 31 May; summit participants will explore options for assessing value and establishing value-based prices for orphan drugs.
The Institute for Clinical and Economic Review (ICER) posted a briefing paper on Assessing the Effectiveness and Value of Drugs for Rare Conditions. The briefing paper seeks to provide background information to help frame the issues to be discussed during ICER’s Orphan Drug Assessment and Pricing Summit, a multi-stakeholder policy meeting to be held in Washington, DC on 31 May.
FDA approves Merck’s Keytruda (pembrolizumab) as first-line combination therapy with pemetrexed and carboplatin for patients with metastatic non-squamous non-small-cell lung cancer, irrespective of PD-L1 expression
10 May 2017 — First approval for an anti-PD-1 therapy as a combination in metastatic non-squamous NSCLC.
Merck today announced that the U.S. FDA has approved Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, in combination with pemetrexed (brand name Alimta) and carboplatin (pem/carbo), a commonly used chemotherapy regimen, for the first-line treatment of metastatic non-squamous NSCLC, irrespective of PD-L1 expression.
Under the FDA’s accelerated approval regulations, this indication is approved based on tumour response rate and progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Novartis heart failure treatment Entresto (sacubitril/valsartan) now available to patients in Ontario through the public provincial drug plan
9 May 2017 — Entresto has been shown to reduce the risk of cardiovascular death and hospitalization in heart failure with reduced ejection fraction.
Novartis Pharmaceuticals Canada is pleased to announce that the heart failure treatment Entresto (sacubitril/valsartan) is now reimbursed by the public provincial drug plan in Ontario.
Entresto is also available through the public drug plans in Quebec, Saskatchewan and the Yukon. Novartis continues to work with other provinces to ensure eligible heart failure patients across Canada have equal access to Entresto™ as soon as possible.
Provincial drug plans, including Ontario and BC, make Entyvio (vedolizumab) available to treat inflammatory bowel disease
9 May 2017 — Gut-selective treatment now funded publicly for Canadians with ulcerative colitis and Crohn’s disease.
Takeda Canada is pleased to announce that several provinces across Canada including Ontario and British Columbia, have agreed to fund Entyvio (vedolizumab), the first and only gut-selective biologic therapy for inflammatory bowel disease through their public provincial drug plans.
Entyvio is now funded in Ontario and British Columbia for adults with moderate or severe biologic-naïve and biologic-experienced ulcerative colitis or Crohn’s disease.
FDA grants Bavencio (avelumab) approval for a common type of advanced bladder cancer
9 May 2017 — Second approval for Bavencio in less than two months.
EMD Serono and Pfizer today announced that the US FDA has approved Bavencio (avelumab) Injection for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Bavencio was previously granted accelerated approval from the FDA for the treatment of adults and paediatric patients 12 years and older with metastatic Merkel cell carcinoma. These indications are approved under accelerated approval based on tumour response and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
