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

Thiru Balasubramaniam thiru at keionline.org
Wed Jul 10 00:45:02 PDT 2019


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

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

“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

“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

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

More information about the Ip-health mailing list