[Ip-health] Letter to HHS and NIH regarding impact of high prices on cost effectiveness of Xtandi

Andrew S. Goldman andrew.goldman at keionline.org
Fri Apr 22 06:29:37 PDT 2016


Yesterday KEI submitted a letter to Secretary Burwell and Director Collins
in support of the KEI/UACT petition that asked the NIH (or the Army) to use
the federal government rights in the patents on the prostate cancer drug
Xtandi, to remedy the excessive and discriminatory price in the United
States. The letter calls attention to findings of an article from the the
Journal of Oncology Pharmacy Practice, in which the authors conclude that a
reduction in price would make Xtandi the most-cost effective option.

The text of the letter follows:


April 21, 2016
The Honorable Sylvia Mary Mathews Burwell
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Via: Sylvia.Burwell at hhs.gov

Francis Collins, M.D., Ph.D.
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892
Via: Francis.Collins at nih.hhs.gov

Dear Secretary Burwell and Director Collins:

We have recently become aware of academic research indicating that the
price of Xtandi (enzalutamide) is a primary factor in determinations by
payors that restrict access to the medicine. I submit this research as
evidence to supplement our petition, particularly the discussion under the
second subheading (“The high prices for Xtandi create hardships on U.S.
patients”) on pages five through nine, in which we detailed, inter alia,
how insurers in the U.S. were restricting access to Xtandi due to the high
price. [1]

Our petition suggested that one option to increase access to generic
enzalutamide would be for the Department of Health and Human Services or
the National Institutes of Health to use the royalty-free rights in patents
under 35 USC § 202(c)(4), which offers the path of least resistance under
the Bayh-Dole Act. With regard to exercising march-in rights, our argument
primarily focused on 35 USC § 203(a)(1) and the requirement of “practical
application,” as defined under 35 USC § 201(f) to require public
availability “on reasonable terms.” But equally applicable, particularly in
light of this new evidence, is 35 USC § 203(a)(2), which provides that
“action is necessary to alleviate health or safety needs which are not
reasonably satisfied by the contractor, assignee, or their licensees.”

In 2014, a study published by Leslie Wilson et al. calculated the cost
effectiveness of three metastatic castration-resistant prostate cancer
(mCRPC) treatments -- Zytiga (abiraterone), Xtandi (enzalutamide), and
Jevtana (cabazitaxel) -- and found that the price of Xtandi is the single
limiting factor rendering Xtandi less cost-effective than Zytiga. This
study was detailed in the Journal of Oncology Pharmacy Practice:

L. Wilson et al. New therapeutic options in metastatic castration-resistant
prostate cancer: Can cost-effectiveness analysis help in treatment
decisions? Journal of Oncology Pharmacy Practice 2014, Vol. 20(6) 417–425

According to the authors’ incremental cost-effective calculations based
upon 2012 prices, Xtandi would be the preferred treatment, if prices were

Results: Abiraterone was the most cost-effective of the treatments ($123.4
K/quality-adjusted life year) compared to placebo, enzalutamide was $437.6
K/quality-adjusted life year compared to abiraterone, and cabazitaxel was
$351.9 K/ quality-adjusted life year compared to enzalutamide. Enzalutamide
and cabazitaxel were not cost-effective compared to placebo at $154.3
K/quality-adjusted life year and $163.2 K/quality-adjusted life year,
respectively. Acceptability curves showed abiraterone was cost-effective
29.3% of the time with a willingness to pay threshold of $100 K. The model
was sensitive to changes in cost of the drugs, life expectancy, and
survival rate. *Sensitivity analysis shows that enzalutamide can become the
most cost-effective option if the price of the medication decreased by 26%
and other drug costs remained the same.* [emphasis added]

The Wilson paper concludes with this comment:

The results of our study can be useful in setting funding priorities for
programs that are competing for scarce resources by making comparisons
across all available treatment options.

This research illustrates way that health care providers will respond to
the excessive and discriminatory pricing of Xtandi. When prices are high,
access to enzalutamide is downgraded in formularies, even when it is
otherwise a superior treatment for patients.

The restriction of access is a dangerous and unnecessary risk taken with
the lives of mCRPC patients, and one that begs for action to alleviate the
health needs directly caused by Astellas’s pricing. As we pointed out in
our petition, the ramifications of forcing patients to take other mCRPC
drugs prior to Xtandi can include a decrease in the effectiveness of
Xtandi, or complete resistance.[2] Patients in treatment for prostate
cancer already face enough challenges without the added risks associated
with the excessive and discriminatory pricing of Xtandi.

A copy of the article is enclosed.


Andrew S. Goldman
Counsel, Policy & Legal Affairs
Knowledge Ecology International
1621 Connecticut Avenue, Suite 500
Washington, DC 20009
andrew.goldman at keionline.org

Diane Singhroy
Scientific and Technical Advisor
Knowledge Ecology International
diane.singhroy at keionline.org

[1] The KEI/UACT petition regarding Xtandi is available here:
[2] See p.4 of the KEI/UACT petition.

Andrew S. Goldman
Counsel, Policy and Legal Affairs
Knowledge Ecology International
andrew.goldman at keionline.org // www.twitter.com/ASG_KEI
tel.: +1.202.332.2670

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