Global Pricing Insights – Last Week In Review – April 25 – 29, 2022

NAVLIN BRIEF:

  • President Joe Biden proposed a $35 a month cap on insulin, a “steep tax” on drug companies that increase prices faster than the rate of inflation, a $2,000 annual limit on prescription drug spending for senior Medicare beneficiaries, and, most notably, empowering Medicare to negotiate drug prices with companies. As the President sees it, Medicare would not purchase drugs from a company “beyond a certain price,” adding, “It doesn’t mean you can’t continue to manufacture and ask a billion dollars for it… But the federal government is not going to pay for it”. Biden’s push for a cap on insulin will potentially come into fruition, since the U.S. House of Representatives passed the Affordable Insulin Now Act in a 232-193 vote at the beginning of April.
  • During its April 2022 meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended four new medicines and several indication extensions. Leading the meeting was Amryt Pharmaceuticals Filsuvez (birch bark extract) to treat epidermolysis bullosa (EB) – Filsuvez is indicated to treat partial-thickness wounds associated with dystrophic and junctional EB in patients six months and older. According to Amryt, results from the EASE trial have shown an improvement versus control gel in terms of the proportion of patients with complete closure of the target wound within 45 days of treatment. In addition to the positive opinions, the CHMP recommended seven extensions of indication for medicines that are already authorized in the EU: Bydureon (exenatide), Elonva (corifollitropin alfa), Keytruda (pembrolizumab), NovoSeven (eptacog alfa), Retsevmo (selpercatinib), Tecentriq (atezolizumab), and Yescarta (axicabtagene ciloleucel).
  • The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan). The designation is for Enhertu for the treatment of adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurring during or within six months of completing adjuvant chemotherapy.

THE DETAILS

COVID-19

The U.S. will be increasing access to Pfizer’s oral COVID-19 antiviral, Paxlovid (nirmatrelvir and ritonavir), announced U.S. President Joe Biden. The government committed to purchase 20 million treatment courses and the Biden administration worked with Pfizer come up with a plan to expedite the delivery of Paxlovid. Key actions of the U.S.’s plan include nearly doubling the number of places where oral antivirals are available in the coming weeks, launching a new effort to stand up federally-supported Test-to-Treat sites, supporting medical providers with more guidance and tools to understand and prescribe treatments, and communicating to the American people that safe, effective treatments are widely available.

Stella Kyriakides, European Commissioner for Health and Food Safety, has suggested that the EU is entering a post-emergency phase of the pandemic, pivoting to treat the disease in the same way as a regular flu would be. Speaking at a press conference on COVID-19, the Commissioner announced that the “situation has stabilized thanks to the strong coordination at EU level,” before going on to present a new approach to the virus, “setting out actions to help us all to look ahead and move from emergency to a more sustainable management of the pandemic.” Under the initiative, the Union also wants to strengthen overall pandemic preparedness, by improving access to COVID-19 vaccines and therapeutics globally.

The European Medicines Agency (EMA) has recommended authorizing the use of Pfizer-BioNTech’s COVID-19 vaccine, Comirnaty, as a booster for adults who have previously been inoculated with other vaccines. Some countries have already begun rolling out a fourth dose for those at higher risk; however, as reported earlier this month, the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency’s (EMA) COVID-19 task force (ETF) advised that it was too early to consider using a fourth dose of mRNA COVID-19 vaccines such as Comirnaty or Moderna’s Spikevax in the general population.

Federal Ministry of Health (BMG) has announced that it will continue to maintain COVID-19 related exception rules on drug supply for future health crises. As reported in 2020, during the COVID-19 pandemic, the BMG presented an additional draft emergency ruling, the Medical Need Care Provision Ordinance (MedBVSV), under the Infection Protection Act, that would exempt certain drugs from regulatory requirements, including drug law and drug trade law, to ensure the adequate supply of medicines. According to the BMG, the ordinance would be amended to allow the delivery of a drug that has not been approved in Germany based on a risk-benefit assessment made by the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI) in a crisis.

Pfizer has submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of Comirnaty as a booster for children aged 5 to 11.

Japan’s Health Science Council’s (HSC) immunization and vaccine subcommittee has authorized use of Novavax’s COVID-19 vaccine via a program which provides free emergency vaccinations. The panel determined that the Novavax shot can be given as a first dose, booster shot, or a third dose, regardless of which vaccine the person had received previously.

POLICY

President Joe Biden proposed a $35 a month cap on insulin, a “steep tax” on drug companies that increase prices faster than the rate of inflation, a $2,000 annual limit on prescription drug spending for senior Medicare beneficiaries, and, most notably, empowering Medicare to negotiate drug prices with companies. As the president sees it, Medicare would not purchase drugs from a company “beyond a certain price,” adding, “It doesn’t mean you can’t continue to manufacture and ask a billion dollars for it… But the federal government is not going to pay for it”. Biden’s push for a cap on insulin will potentially come into fruition, since the U.S. House of Representatives passed the Affordable Insulin Now Act in a 232-193 vote at the beginning of April.

Medicines for Europe has urged Central and Eastern European (CEE) governments to invest in off-patent medicines to improve the “inequitable” access to medicines currently facing the CEE region, which has largely been caused by poor pricing policies. The group has recommended CEE governments invest in the off-patent sector, with government initiatives focusing on ensuring predictable market policies and avoiding extreme price pressure, encouraging the use of off-patent medicines with compelling incentives for stakeholders, and avoiding restrictive prescription guidelines that delay patient access to essential treatment.

At the end of last year, the European Commission opened a new public consultation on the revision of the EU’s pharmaceutical legislation, as part of the ongoing work for the Pharmaceutical Strategy for Europe. On Monday, May 2, stakeholders are set to meet in Brussels to discuss the regulatory framework surrounding the review, and offer input based on the feedback received so far. The meeting “workshop” will discuss the progress so far by the Commission regarding the legislative process, to help it deliver formal proposals before the end of this year. According to the Commission, the plan is based on four specific pillars, which include legislative and non-legislative action such as access to affordable medicines, and support for competition and innovation.

The Colombian Ministry of Health and Social Protection (MINSALUD) will be cooperating with the Ministers of Health of the Caribbean Region (CARICOM) to aid these countries in advancing their health systems, with a focus on hospital integration, medicine regulation, and the COVID-19 pandemic.

At the 34th extraordinary meeting of Andean health ministers (REMSAA), attendees discussed the formation of a mechanism for joint-Andean negotiation and acquisition of medicines and supplies. Together, the member countries want to promote joint procurement of medicines and supplies at the Andean level to make up for “evident inequities and weaknesses in the health systems”. The health ministers from Bolivia, Colombia, Ecuador, Chile, Peru, and Venezuela are part of the Andean Health Organization – Hipolito Unanue Agreement (ORAS-CONHU), a subregional organization with the aim of coordinating and supporting one another’s efforts to improve health.

HTA

The High Health Authority of France (HAS) has granted an early access scheme (ATU) to Vifor’s Kapruvia (difelikefalin) for the treatment of moderate forms of pruritus associated with chronic kidney disease (CKD) in adult patients on hemodialysis.

The Institute for Quality and Efficiency in Health Care (IQWiG) says that there is “room for improvement” for pharmaceutical companies’ health technology assessment (HTA) practice data. In 2020, IQWiG published criteria for the usability of routine practice data in the benefit assessment of drugs. The rapid report gave manufacturers and registry operators concrete recommendations for collecting and analyzing routine practice data. However, according to Jürgen Windeler, Director of the handling of routine practice data at IQWiG, there is a gap between the internationally accepted methods the Institute described in the rapid report.

The High Health Authority of France (HAS) has granted an early access scheme (ATU) to Novartis’ Scemblix (asciminib) for chronic myeloid leukemia (CML).

The Swedish Dental and Pharmaceutical Benefits Agency (TLV) has made the decision not to include Eli Lilly’s Baqsimi (glucagon) in the country’s high-cost protection system. Baqsimi is a medicine used to treat severe hypoglycemia (very low blood glucose levels) in adults and adolescents who have diabetes.

 PRICING & REIMBURSEMENT 

Polish Deputy Minister of Health, Maciej Miłkowski, has confirmed that the reimbursement list of innovative therapies is still under construction. Earlier this year, the Agency for Health Technology Assessment and Tariff System (AOTMiT) published a list of 21 drug technologies with high innovation, including the definition of expected health benefits and indicators for assessing the effectiveness of therapy. The list is currently in consultation with other relevant entities, Miłkowski confirmed. However, he added that not all therapies submitted will be able to be reimbursed, due to the high nature of their costs.

Poland’s Ministry of Health has announced that it will reimburse two new tisagenlecleucel (CAR-T) therapies from May 1. Deputy Minister of Health Maciej Miłkowski said that adult patients with relapsed or refractory large B-cell lymphoma treated with CAR-T in certified centers will be fully financed by the National Health Fund. Responding to the Minister, Marta Wielondek, General Manager of Novartis Oncology Poland, said this is a breakthrough moment for Polish patients as “for years, scientists have been searching for different ways to harness the immune system to fight cancer. CAR-T technology is definitely one of the greatest discoveries.”

In its latest meeting, Norway’s New Methods Committee approved the introduction of Vertex’s portfolio of cystic fibrosis (CF) therapies. The Kaftrio (ivacaftor / tezacaftor / elexacaftor), Symkevi (tezacaftor / ivacaftor), Kalydeco (ivacaftor) and Orkambi (lumacaftor / ivacaftor). Inger Cathrine Bryne, Head of Decision Forum and CEO of Helse Vest, said: “We are very pleased that we have reached an agreement with Vertex. This will mean a lot –primarily for the patients in Norway but also for relatives and clinicians. We know that many people have waited a long time for this treatment to become available.”

The Italian Medicines Agency (AIFA) has published its first report detailing the impact of simplified negotiation procedures for generics and parallel imported medicinal products, introduced in 2020 and 2021, respectively. According to AIFA, the two pathways have ultimately had a positive impact on the healthcare system, as the processing time reduction has an “economic advantage” for the SNS, as well as allowing an increase in the availability of medicines in each therapeutic area, thus fostering greater competition. Concluding the report, AIFA noted that the request for reimbursement and price is “considered constant over time” with an average annual number of equal procedures to 858, 55% generic drugs, biosimilars, copying and parallel imports.

Amarin’s partner HLS Therapeutics announced it has completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for the reimbursement of Vascepa (icosapent ethyl). HLS will now work with all stakeholders to secure coverage from public drug plans in Canada to ensure Vascepa is added to these plans. The company anticipates the drug will be “progressively added” to provincial and territorial formularies over the next few months.

The High Health Authority (HAS) of France has published a favourable opinion for the reimbursement of Incyte’s orphan drug, Minjuvi (tafasitamab), in combination with Bristol Myers Squibb’s Revlimid (lenalidomide), followed by Minjuvi as monotherapy for the treatment of adult patients with diffuse large B-cell lymphoma only.

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) has put forward a number of proposals to help modernize the existing centralized procedure and aid the evolution of the regulatory framework. The group has called for “improvements along the value chain, accompanied by the updated scope of the centralized procedure,” as well as simplification of its “complex” workings. With the three key proposals, EUCOPE believes that reforms can help make the EU a more competitive region for investment and ultimately help patients access drugs faster.

DRUG APPROVAL

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan). The designation is for Enhertu for the treatment of adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurring during or within six months of completing adjuvant chemotherapy.

Both the U.S. Food and Drug Administration (FDA) and European Commission (EC) have granted Orphan Drug Designation to AviadoBio’s one-time gene therapy, AVB-101 for the treatment of frontotemporal dementia.

Biogen announced that it has notified the European Medicines Agency (EMA) of its decision to withdraw its Marketing Authorization Application (MAA) for its Alzheimer’s disease therapy, Aduhelm (aducanumab). According to Biogen, it withdrew the application as the EMA’s Committee for Medicinal Products for Human Use (CHMP) indicated that the data provided thus far would not be sufficient to support a positive opinion on the marketing authorization of Aduhelm.

The U.S. Food and Drug Administration (FDA) has approved Gilead’s supplemental New Drug Application (sNDA) regarding pediatric use of Veklury (remdesivir). Veklury is approved for the treatment of pediatric patients who are older than 28 days, weigh at least 3 kg, and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 symptoms and are at high risk for serious disease including hospitalization or death.

During its April 2022 meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended four new medicines and several indication extensions. Leading the meeting was Amryt Pharmaceuticals Filsuvez (birch bark extract) to treat epidermolysis bullosa (EB). Filsuvez is indicated to treat partial-thickness wounds associated with dystrophic and junctional EB in patients six months and older. According to Amryt, results from the EASE trial have shown an improvement versus control gel in terms of the proportion of patients with complete closure of the target wound within 45 days of treatment. In addition to the positive opinions, the CHMP recommended seven extensions of indication for medicines that are already authorized in the EU: Bydureon (exenatide), Elonva (corifollitropin alfa), Keytruda (pembrolizumab), NovoSeven (eptacog alfa), Retsevmo (selpercatinib), Tecentriq (atezolizumab), and Yescarta (axicabtagene ciloleucel).

Uruguay has approved BeiGene’s BTK inhibitor, Brukinsa (zanubrutinib) for the treatment of adults with previously treated mantle cell lymphoma (MCL), relapsed or refractory (R/R) marginal zone lymphoma (MZL), and Waldenström’s macroglobulinemia (WM).

The European Medicines Agency (EMA) has granted access to the Priority Medicines (PRIME) scheme for BioCryst’s BCX9250, a novel, oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva (FOP).

Learn more about NAVLIN by EVERSANA and our Global Pricing Solutions!

Contact us with your questions and global pricing needs, and an expert will follow up shortly.