Healthy Skepticism Library item: 7480

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Lilly questions PBAC review process
Pharma in Focus 2007 Jan 15
http://www.pharmainfocus.com.au/news.asp?newsid=1469

Abstract:

Eli Lilly has said the Independent Review process for PBAC decisions may
not be appropriate for resolving data issues following its fifth failure
to win a positive recommendation for reimbursement of Forteo (teriparatide).

The company initiated an Independent Review after the PBAC knocked back
Forteo for the fourth time in March 2006.

“Lilly was satisfied that the process of the Independent Review was
transparent and appropriate. However in cases of severe patient need
where the data is limited and open to interpretation, the Independent
Review will not always be the most appropriate mechanism to resolve
outstanding barriers to listing a much-needed medicine on the PBS,” the
company said in a statement following the release of the PBAC’s November
decision to stick to its previous view.

Lilly is so far the only company to request an independent review of a
PBAC decision under the Australia/US Free Trade Agreement. “While the
Independent Review offered some support to Lilly’s arguments regarding
the biological basis for Forteo’s clinical benefits, the PBAC did not
consider the Review’s findings warranted a change in its previous
decisions,” the company said.

The Review said there was insufficient rigor in the clinical trial data
analysis to recommend acceptance of the material presented in the
submissions.

It agreed with the PBAC’s position. “In particular, the validity and
robustness of the post-hoc subgroup analysis is a major deficiency. This
results in an interpretation of unclear therapeutic benefit for
teriparatide over comparator therapy,” it said.

Lilly was again critical of the PBAC’s decision, saying, “Lilly believes
it is unfair to the predominantly elderly patients, who are already
physically compromised, to be denied access to an effective medicine
that is registered for the most severe forms of osteoporosis. Without
effective treatment, patients face a life of severe pain, significantly
reduced quality of life and can require hospitalisation and
rehabilitation for extended periods of time.”

“The price offered to the PBAC in the last submission was already
amongst the lowest of any country within the Organisation for Economic
Co-operation and Development (OECD). England, France, Sweden and
Scotland have all recently recommended Forteo for subsidy in severe
osteoporosis where fractures continue to occur despite previous
treatment with currently available options,” the company said.

In releasing its decision on Forteo, the PBAC said the review provided
no new basis to warrant reconsideration of its March 2006 recommendation.

Lilly said, however that it strongly believed adequate information
existed to demonstrate Forteo’s clinical and cost effectiveness.

“Lilly has been investigating all options to table before the PBAC to
find ways to make this medicine more accessible, including the provision
of emerging additional data. We urge the PBAC to adopt a
solutions-oriented approach that will ensure patients in Australia have
access to a medication proven to be effective for their condition,” the
company said.