Global Pricing Insights – Last Week In Review – June 6 – 10 , 2022

NAVLIN Brief

  • The Department of Health and Social Care (DHSC) has announced that £340 million has been made available to the Innovative Medicines Fund (IMF) to purchase the most promising drugs, which will be fast-tracked to National Health Service (NHS) patients in England. The funding further supports NHS England in offering patients potentially transformative new drugs while further real-world evidence (RWE) is collected to inform a final decision by the National Institute for Health and Care Excellence (NICE) on whether the treatment is cost and clinically effective and a good use of taxpayer money in the long-term, reducing delays and boosting patient outcomes in the interim.
  • The Federal Trade Commission (FTC) announced it will be launching an inquiry into the business practices of the six largest Pharmacy Benefit Managers (PBMs), CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. Their inquiry will examine the role of these pharmacy middlemen at the center of the U.S. pharmaceutical system to bring more transparency to their practices. FTC aims to shed light on fees and clawbacks charged to unaffiliated pharmacies; methods to steer patients towards PBM-owned pharmacies; potentially unfair audits of independent pharmacies; complicated and opaque methods to determine pharmacy reimbursement; the prevalence of prior authorizations and other administrative restrictions; the use of specialty drug lists and surrounding specialty drug policies; and the impact of rebates and fees from drug manufacturers on formulary design and the costs of prescription drugs to payers and patients.
  • Quebecois Minister of Health and Social Services (MSSS) Christian Dubé and parliamentary assistant Marilyne Picard have unveiled Quebec’s first Policy for Rare Diseases, which aims to boost access to quality health care and services that meet the specific needs of patients suffering from rare diseases. Based on three axes, each of which are divided into concrete objectives, the plan seeks to raise awareness and training, particularly for health professionals; make it easier to access diagnosis, care, and services; and promote research, innovation, and data collection (full summary of policy provided in article). Quebec has set up an advisory committee to implement the plan over the next few months, with several sub-committees focused on specific rare diseases.

THE DETAILS

COVID-19

Pfizer announced it will invest $120 million at its Kalamazoo, Michigan facility to support the production of its COVID-19 oral antiviral treatment, Paxlovid (nirmatrelvir and ritonavir). With the investment, Pfizer plans on broadening production of the active pharmaceutical ingredient (API) and registered starting materials (RSMs) needed for the novel main protease inhibitor in Paxlovid called nirmatrelvir. Expanding the Kalamazoo facility will make it one of the world’s most robust API producers, churning out 1,200 metric tons per annum.

At the first Africa Health ExCon in Cairo, Egyptian President Abdel Fatah al-Sisi pledged to provide 30 million COVID-19 vaccines to African states. Along with Senegal, Kenya, South Africa, Tunisia, and Nigeria, Egypt is one of six African states set to receive mRNA technology needed to produce COVID-19 vaccines. Egypt’s state-owned VACSERA is manufacturing Sinovac’s COVID-19 vaccines. In February of this year, Egypt produced over 30 million doses of the Sinovac COVID-19 vaccine.

The Ministry of Health of Latvia, together with several European Union (EU) Member States, have sent a formal request to the European Commission (EC) to review the terms of the contracts concluded with the manufacturers of COVID-19 vaccines to make them more flexible and allow Member States to receive vaccines according to their needs. According to Latvia’s Ministry of Health, the agreements require each Member State to purchase the amount of vaccines pre-ordered, despite the fact that with the increase in vaccination coverage and the gradual reduction of the pandemic, the need to purchase all vaccines applied for by member states during the outbreak of the pandemic is lost. As reported, a number of EU member states have been donating surplus vaccines, including Poland, which plans to stop accepting COVID-19 vaccines under the EU-led joint procurement initiative.

POLICY

The Department of Health and Social Care (DHSC) has announced that £340 million has been made available to the Innovative Medicines Fund (IMF) to purchase the most promising drugs, which will be fast-tracked to National Health Service (NHS) patients in England. The funding further supports NHS England in offering patients potentially transformative new drugs while further real-world evidence (RWE) is collected to inform a final decision by the National Institute for Health and Care Excellence (NICE) on whether the treatment is cost and clinically effective and cost-effective and a good use of taxpayer money in the long-term, reducing delays and boosting patient outcomes in the interim.

The Federal Trade Commission (FTC) announced it will be launching an inquiry into the business practices of the six largest Pharmacy Benefit Managers (PBMs), CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. Their inquiry will examine the role of these pharmacy middlemen at the center of the U.S. pharmaceutical system to bring more transparency to their practices. FTC aims to shed light on fees and clawbacks charged to unaffiliated pharmacies; methods to steer patients towards PBM-owned pharmacies; potentially unfair audits of independent pharmacies; complicated and opaque methods to determine pharmacy reimbursement; the prevalence of prior authorizations and other administrative restrictions; the use of specialty drug lists and surrounding specialty drug policies; and the impact of rebates and fees from drug manufacturers on formulary design and the costs of prescription drugs to payers and patients.

The Indian Government is set to come up with a list of 16 over-the-counter (OTC) medicines under Schedule K by amending the Drugs Law, 1945, with stringent regulations on quality, pricing, and advertisement of such products. The Indian Union Health and Family Welfare Ministry has issued a draft notification published in the Gazette of India seeking suggestions from stakeholders within 30 days. The 16 medicines include Povidone Iodine, an antiseptic and disinfectant agent; Chlorohexidine mouthwash for gingivitis; Clotrimazole, an antifungal cream; Clotrimazole dusting powder; Dextromethorphan Hydrobromide lozenges for cough; Diclofenac, analgesic ointment; Benzoyl peroxide, an antibacterial for acne; Diphenhydramine Capsules, antihistaminic and antiallergic drug; Paracetamol; Calamine Lotion (Antiseptic); Ketoconazole shampoo, anti-dandruff; some nasal decongestants, and laxatives.

Quebecois Minister of Health and Social Services (MSSS) Christian Dubé and parliamentary assistant Marilyne Picard have unveiled Quebec’s first Policy for Rare Diseases, which aims to boost access to quality health care and services that meet the specific needs of patients suffering from rare diseases. Based on three axes, each of which are divided into concrete objectives, the plan seeks to raise awareness and training, particularly for health professionals; make it easier to access diagnosis, care, and services; and promote research, innovation, and data collection (full summary of policy provided in article). Quebec has set up an advisory committee to implement the plan over the next few months, with several sub-committees focused on specific rare diseases.

HTA

In a U-turn decision, the National Institute for Health and Care Excellence (NICE) has recommended Vazkepa (Icosapent ethyl) as an option for reducing the risk of cardiovascular events in adults. As reported in March, NICE initially turned down Amarin’s Vazkepa, citing concerns with the company’s economic model mean cost-effectiveness estimates for the drug, with estimates breaching the range NICE considers an acceptable use of NHS resources. However, Helen Knight, interim director of medicines evaluation at NICE, said, “we have worked closely with the company to identify the population most likely to gain the greatest benefit from Icosapent ethyl, striking a balance between effectiveness and the best use of public funding, delivering maximum value to the taxpayer.”

The introduction of a methodology into the scoping process and the adaptation of guidelines to assess products across 27 countries are needed for a joint European Union (EU) Health Technology Assessment (HTA), say experts. In a panel discussion on “Piloting the EU HTA before 2025,” Adam Parnaby, Vice-Chair EFPIA HTA WG & Senior Director, Market Access Policy, BMS, underscored that “we can look at all sorts of different areas and see that prescribing patterns are different across Europe.”  The starting point for every health technology assessment is the scoping phase. During the scoping phase, an important goal is the definition of a concise research question that should be answered by the assessment. However, according to Parnaby, there is an argument to be made to introduce a methodology into the scoping “because of the need to develop a comparative for some populations on scientific principles of evidence-based medicine.”

The transparency committee (TC) of the French National Authority of Health (HAS) is in favor of reimbursing an indication extension of Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with Kalydeco (ivacaftor) in the treatment of cystic fibrosis patients aged six years and older with at least one F508del mutation in the CFTR (Cystic Fibrosis Transmembrane Regulator) gene.

PRICING & REIMBURSEMENT

The Italian Competition Authority (AGCM) has fined Leadiant Group €3.5 million for charging the Italian National Health Service (SSN) excessive prices for the life-saving rare disease drug, chenodeoxycholic acid (CDCA), which is used for the treatment of cerebrotendineous xanthomatosis (CTX). According to AGCM, Leadiant has “abused its dominant position held in the Italian market for the production and sale of drugs containing CDCA,” which the authority said is “very serious,” considering the life-saving nature of the drug. Last July, the Netherlands Authority for Consumers and Markets (ACM) likewise concluded Leadiant charged too much for CDCA, fining the company €19,569,500, although Leadiant CEO de Silva stated, “We are convinced that we have always acted correctly and in compliance with all applicable regulations.”

Switzerland’s Federal Council has proposed measures to increase the equal treatment of patients, accelerate the process of inclusion in the list of drugs, and curb costs. The measures require an amendment to the Health Insurance Ordinance (KVV) and the Health Care Benefits Ordinance (KLV). The consultation will start on June 3, 2022. and will last until September 30, 2022. The amended ordinances are expected to enter into force in the first half of 2023. First, the Federal Council intends to further improve rapid and cost-effective access to medicinal products in the interests of patients. According to the Council, a pharmaceutical company is now to be given the opportunity to carry out a preliminary clarification with the Federal Office of Public Health (FOPH) even before it has submitted an application for admission to the list of specialist medicines (SI).

Astellas’ Evrenzo (roxadustat) has bagged a recommendation from the UK’s National Institute for Health and Care Excellence (NICE) as a treatment option for adults with anemia associated with chronic kidney disease (CKD). Evrenzo was shown to work just as well as erythropoiesis stimulating agent (ESA), darbepoetin alfa in a clinical trial, and cost effectiveness estimates for Evrenzo are considered an acceptable use of NHS resources. In January, NICE initially rejected Evrenzo, citing “inappropriate” data pooling, since clinical-effectiveness estimates for roxadustat combined results from trials comparing the drug with placebo.

DRUG APPROVAL

The European Medicines Agency (EMA) has validated SIFI’s Marketing Authorization Application (MAA) for its Akantior (polihexanide) for the treatment of acanthamoeba keratitis (AK). The MAA is backed by the results of the Phase 3 clinical trial, which demonstrated a high medical cure rate. ”Our findings show that Akantior will provide a majority of AK patients the prospect of recovering their vision and quality of life; I hope that this will soon become the standard of care for treatment of this disease,” explained Professor John Dart, principal investigator of the clinical trial.

The U.S. Food and Drug Administration (FDA) has approved GSK’s Priorix (Measles, Mumps, and Rubella Vaccine, Live) for active immunization for the prevention of measles, mumps, and rubella (MMR) in individuals 12 months of age and older.

Bristol-Myers Squibb (BMS) announced it has withdrawn the supplemental Biologics License Application (sBLA) for Reblozyl (luspatercept-aamt) for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia.

The Health Sciences Authority (HSA) of Singapore has approved Astellas’ Padcev (enfortumab vedotin) as monotherapy for the treatment of adults with locally advanced or metastatic urothelial carcinoma (UC).

Health Canada has approved BioCryst’s Orladeyo (berotralstat) for routine prevention of recurrent hereditary angioedema (HAE) attacks in patients age 12 years and up. Orladeyo is an oral, once-daily therapy designed to prevent HAE attacks in adult and pediatric patients by decreasing the activity of plasma kallikrein. Jared Rhines, GM of BioCryst Canada, said, “We look forward to working with stakeholders across the country to ensure these Canadians can receive timely and appropriate access to Orladeyo.”

The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for children age six months to five years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

The European Commission has granted Conditional Marketing Authorization (CMA) to Roche’s CD20xCD3 T-cell engaging bispecific antibody Lunsumio (mosunetuzumab) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies. The approval is backed by the Phase 1/2 GO29781 study results, demonstrating Lunsumio to induce high complete response rates, with the majority of complete responses lasting for at least 18 months in people with heavily pre-treated FL.

The U.S. Food and Drug Administration (FDA) has approved Amgen’s Riabni (rituximab-arrx), a biosimilar to Rituxan, in combination with methotrexate for adults with moderate to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

Vertex Pharmaceuticals announced its investigational therapy, inaxaplin (VX-147) has been granted Breakthrough Therapy Designation in the U.S. and Priority Medicines (PRIME) designation in the European Union.

The European Commission (EC) has approved Roche’s Tecentriq (atezolizumab) as an adjuvant treatment, following complete resection and platinum-based chemotherapy, for adults with non-small cell lung cancer (NSCLC) with a high risk of recurrence whose tumors express PD-L1≥50% and who do not have EGFR mutant or ALK-positive NSCLC.

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