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

James Elliott james at t1international.com
Thu Jul 11 10:53:41 PDT 2019


I also wonder why so many academics are pushing so hard for people living
in low and middle income countries to be on the absolutely the worst
available type 1 diabetes treatments. Especially when

- The costs of producing analogues vs "human" is minimal:
https://gh.bmj.com/content/3/5/e000850
- The time spent on these arguments can be used to bring power to bare on
the insulin oligarchy to lower prices closer to actual manufacturing costs,
as it was done for ART
- Analogue insulins are clearly easier to survive on in low and middle
income contexts; given the lack of blood glucose testing supplies to most
living there, the carb heavy diets, and the necessity of avoiding
hypogylcaemia, the limited hospital facilities for hypoglycemic reaction
rescues etc. etc. etc.
- We continue to feed the narrative that molecules like glargine, detemir
and lispro are breakthrough meds when in fact they have been on market for
20+ years and are already being pushed out of high income market places by
newer molecules like aspart

So yes, many questions, hopefully more people who actually taken these
molecules to survive will be invited to the next round of EML meetings, and
we don't waste time arguing the majority of the world's people with type 1
should be happy with 70/30 mix insulins, reheating glass syringes and
peeing on urine sticks

James


T1International Trustee
Twitter: @t1international | @jandelliott
www.t1international.com



On Thu, Jul 11, 2019 at 3:29 AM Malini Aisola <malini.aisola at gmail.com>
wrote:

> 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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> > Ip-health at lists.keionline.org
> >
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>
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