[Ip-health] Health Policy Watch: New Cancer Drugs Top Entries On WHO Essential Medicines List

Malini Aisola malini.aisola at gmail.com
Wed Jul 10 23:11:07 PDT 2019

Why is the narrative so different for insulin analogues and highly priced cancer drugs? Does WHO think insulin analogues are not being marketing in poor countries? 

> On 10-Jul-2019, at 1:15 PM, Thiru Balasubramaniam <thiru at keionline.org> wrote:
> https://www.healthpolicy-watch.org/new-cancer-drugs-top-entries-on-who-essential-medicines-list/
> New Cancer Drugs Top Entries On WHO Essential Medicines List
> 09/07/2019 by Editorial team
> WHO has added ten new cancer drugs, including some pricey ones, to its 2019
> Essential Medicines List, which provides global guidance to countries and
> health systems about drugs deemed most essential to patients and public
> health systems.
> The addition of major new cancer treatments for melanoma (skin), lung,
> blood and prostate cancers reflects both the rapid pace of cancer drug
> research, as well as the growing need to respond to the worldwide increase
> in cancers and other non-communicable diseases.
> In another long-awaited development, WHO also promoted the abortion drug
> mifepristone-misoprostol from a complementary list to the more select core
> list, which together comprise of over 450 essential medicines. However, it
> preserved a footnote saying that the drug should be used “where permitted
> under national law and where culturally acceptable.” According to some
> observers, internal debates around the characterisation of the abortion
> drug had contributed to a delay in the publication of the Essential
> Medicines List, which had originally been due for release last week.
> In a press release, WHO said that improved survival rates were a key
> criteria for including the new cancer therapies as “essential medicines” –
> even if some of the treatments are costly.
> “The inclusion in this list of some of the newest and most advanced cancer
> drugs is a strong statement that everyone deserves access to these
> life-saving medicines, not just those who can afford them,” said WHO
> Director-General Dr Tedros Adhanom Ghebreyesus in the press release.
> The new cancer therapies included two recently developed immunotherapies
> (nivolumab and pembrolizumab) “that have delivered up to 50% survival rates
> for advanced melanoma, a cancer that until recently was incurable,” the WHO
> release said. The therapies are produced by Bristol-Myers Squibb and Merck
> & Co.
> Other new cancer drugs included Roche’s erliotinib treatment for lung
> cancer, which the report said demonstrated survival benefits similar to
> chemotherapy and improved quality of life. Jannsen Biotech’s abiraterone
> was included for treatment of patients with metastatic prostate cancer,
> while other new treatments were included for leukaemia and multiple
> myelomas.
> The publication of the long-awaited update unleashed a wave of reaction
> from civil society, while sending a ripple through the pharma industry, as
> winners and losing drug candidates were examined and evaluated.
> In South Africa, a coalition of nearly 45 patient advocacy groups said the
> WHO announcement offers new Health Minister Dr Zwelini Mkhize an “historic
> opportunity” to save lives by increasing access to one of the new drugs for
> multiple myeloma on the list, lenalidomide.
> “Currently, the majority of cancer patients in South Africa who could
> benefit from lenalidomide cannot access it due to its prohibitively high
> cost – depriving many people of a chance at life,” said Salomé Meyer, from
> the Cancer Alliance in a blog posted online. In South Africa more than 400
> new cases of multiple myeloma – a blood cancer of the plasma cells of bone
> marrow – are reported annually.
> Other civil society advocates, however, said that WHO did not go far enough
> in embracing other cancer drugs that can improve survival rates for people
> with metastasised cancers.
> James Love, Director of Knowledge Ecology International (KEI), told Health
> Policy Watch that two such breast cancer drugs, pertuzumab and
> trastuzumab–emtansine [TDM1], supported by KEI for inclusion into the list,
> didn’t make it, despite what he described as “robust evidence of efficacy.”
> KEI’s proposal to include abiraterone for prostate cancer, however, was
> accepted.
> “What you now have is a list that has some effective and expensive drugs
> and not others, with a bias against metastasized cancers,” said James Love
> of KEI, of the two breast cancer drugs; KEI had itself proposed inclusion
> of the trastuzumab-emtansine [TDM1] combination.
> The WHO Executive Summary of the Essential Medicines List, on the other
> hand, said that the Committee had postponed inclusion of the these two
> breast cancer drugs pending further analysis, because the benefits of
> pertuzumab had not yet been established with sufficiently large trials, and
> for TDM1, alternative options are available on the list.
> Dr Nicola Magrini, Secretary of the Essential Medicines List Expert
> Committee, noted that the new list is growing “rapidly and convincingly”
> with respect to cancer treatments – and health systems will face serious
> challenges just in responding to the new cancer drugs that have already
> been added to the list.
> The WHO Expert Committee has also proposed a larger scientific and
> technical group meeting next year, together with countries and civil
> society, to discuss current challenges in providing cancer treatments and
> programs that meet the “expected EML [Essential Medicines List] standards,
> which are pretty high now,” he said.
> New High-Priced Cancer Drugs
> Indeed, efficacy is not the only issue involved in the debate over cancer
> drugs. Another key factor is pricing. As the Executive Summary notes, some
> of the cancer drugs chosen for inclusion are “high-priced cancer medicines.”
> Love of KEI said that some of the rejected cancer drugs also would have
> introduced competition to drive down prices. He noted that the decision to
> exclude enzalutamide for treatment of prostate cancer ignores the pricing
> benefits that its inclusion would generate through competition with
> abiraterone, a drug that was accepted, but that carries a very high price.
> Love said that exclusion of enzalutamide also could undermine efforts such
> as those by students at UCLA to convince the university to drop a patent
> suit in India against production of generic versions of the patented drug,
> marketed as Xtandi. Generic production would dramatically lower the price
> of enzalutamide, which currently costs around US$ 5,000 a month in India.
> Love also noted that since enzalutamide is a monotherapy with smaller
> active ingredient (API) requirements than abiraterone, it would eventually
> become much cheaper to manufacture, making it a good option in terms of
> both efficacy and pricing in the long-term.
> First All-Oral Drug for Sleeping Sickness
> The latest Essential Medicines List also includes the first all-oral
> treatment for sleeping sickness, fexinidazole, an important milestone in
> the treatment of this neglected, and usually fatal, disease.
> Registered by Sanofi and developed in clinical trials led by the Drug for
> Neglected Diseases initiative (DNDi), fexinidazole is used to treat the
> first and second stages of sleeping sickness, also known as Human African
> Trypanosomiasis, transmitted by the bite of a tsetse fly.
> “65 million people, who live mainly in rural parts of East, West and
> Central Africa, are at risk of contracting sleeping sickness,” DNDi said in
> a statement.
> Inclusion of the first all-oral drug in the Essential Medicines List “will
> spur governments in endemic countries to include fexinidazole in their
> treatment guidelines,” said Dr Nathalie Strub-Wourgaft, DNDi’s Director of
> Neglected Tropical Diseases, in the statement. “Inclusion of fexinidazole
> is also a further sign of WHO and Sanofi’s commitment to ensuring swift
> deployment of this paradigm-changing treatment.”
> Insulin Analogues Not Included
> During the WHO Expert Committee on the Selection and Use of Essential
> Medicines meeting in April of this year, debates were heated over how to
> address the rising cost of insulin, a life-saving essential medicine that
> has been available for nearly 100 years.
> Some proposed for the inclusion of insulin analogues, an altered form of
> human insulin, to increase competition, but others strongly opposed this,
> noting that the high cost of insulin analogues – 8-11 times that of insulin
> – could actually drive insulin prices up.
> The Committee ultimately decided not to include insulin analogues in the
> list, recognising “the need for a wider understanding of the complexities
> of access to insulin and the current insulin market,” and recommending that
> “WHO prioritize the coordination of a series of actions to address the
> issues of insulin access and affordability,” according to the Executive
> Summary.
> “In the absence of other coordinated actions, the Committee considered that
> the inclusion of insulin analogues for adults on the EML [Essential
> Medicines List] would be inadequate to address the underlying issues of
> poor access and affordability of insulins,” it said.
> Abortion Drug Moved to Core List, No Longer Requires Close Supervision
> The drug combination mifepristone–misoprostol, used to end pregnancies that
> are less than 10 weeks along, was recommended by the Expert Committee to be
> moved from the complementary to the more select core list of medicines, and
> for the two drugs to be co-packaged.
> The Committee further recommended the removal of the note accompanying the
> listing that the drug “Requires close medical supervision,” explaining in
> the Executive Summary that this is “based on the evidence presented that
> close medical supervision is not required for its safe and effective use.”
> The Committee, however, noted that “its mandate did not extend to providing
> advice regarding the statement ‘Where permitted under national law and
> where culturally appropriate.’”
> Recommendations on Improving Access to and Affordability of Essential
> Medicines
> In the Executive Summary, the Committee noted that throughout its April
> meeting to review and update the Essential Medicines List, issues of access
> to and affordability of the essential medicines was a core theme,
> particularly in the context of the rising cost of insulin and the high
> prices for the newly added cancer drugs. It further noted that this issue
> of affordability applies both to health systems and to patients.
> While it acknowledged the “limited role of WHO in price setting at country
> level,” it “identified several different actions that could contribute to
> making some of the recently listed essential medicines more affordable at
> country level,” which include:
>   - A wider adoption of biosimilars, which are the equivalent of generics
>   for biologically-based drugs;
>   - Expanding the remit of the Medicines Patent Pool, which negotiates
>   with patent holders for licences of priority drugs to so as to make them
>   available to low- and middle-income countries;
>   - Expand the role of pooled procurement/tendering of drugs;
>   - Use of patent flexibilities [available for health products], in the
>   1995 World Trade Organization (WTO) agreement on Trade Related Aspects of
>   International Property Rights (TRIPS);
>   - Other existing instruments, such as competition law;
> Elaine Fletcher and David Branigan wrote this story.
> -- 
> Thiru Balasubramaniam
> Geneva Representative
> Knowledge Ecology International
> 41 22 791 6727
> thiru at keionline.org
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