This is one of several Wikileaks cables on Poland pharmaceutical reimbursements.
Some highlights from this cable:
- Pfizer’s head of government affairs estimated it contains about 10 new molecules without generic competitors. Meaningful access to the Polish market often hinges on a drug appearing on the list, since those drugs are subsidized by the National Health Fund (NFZ) and doctors most often prescribe drugs from the list.
- Eli Lilly’s Zyprexa was added to the list. Lilly had requested USG assistance in communicating with the Health Ministry regarding their application to put Zyprexa on the list.
- U.S. pharmaceuticals company contacts told EconOff that sales of some of their products already on the list will benefit from having co-payments reduced or eliminated. Furthermore, 24 “combination” products” — one pill comprised of two substances already on the list — were added. Such combinations may be preferred by patients and doctors, and are more challenging to manufacture thus potentially giving U.S. innovative producers an edge.
- Industry officials also continue to be troubled by the role of the Health Technology Assessment Agency (HTA). Polish law allows the Minister to request a cost-benefit analysis from the HTA. In 2008, the Ministry began doing this for all innovative drugs.
- HTA provides its services to the Ministry pursuant to a contract, and consequently does not see itself as a “partner for collaborating with companies.”
- HTA has become a key gatekeeper in the reimbursement process, and complaints about it being a “black box” appear justified.
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SUBJECT: HEALTH MINISTRY UPDATES REIMBURSEMENT LISTWARSAW 00000046 001.2 OF 002
Classified By: Economic Counselor M. Sessums for reasons 1.4(b,d)1. (SBU) Summary: Poland’s Ministry of Health has released an update to its reimbursement list. The updated list contains about 10 innovative drugs that do not have generic competitors, and some of those are manufactured by U.S. companies. U.S. companies will also benefit from reductions in required co-payments and the addition of “combination” products to the list. The changes to the list will increase Poland’s health care costs by about PLN 250 million (about USD 83 million) per year. While the list is good news for some companies, U.S. investors remain troubled by the Ministry’s lack of transparency. It takes about four or five months to obtain a meeting at the Ministry, and the processes for deciding which drugs to add to the reimbursement list remain as mysterious as ever. End summary.
2. (C) Poland’s Ministry of Health released for public comment an update to its “reimbursement list” on December 31. Pharmaceutical companies are still analyzing the list, which is months overdue, but Pfizer’s head of government affairs estimated it contains about 10 new molecules without generic competitors. Meaningful access to the Polish market often hinges on a drug appearing on the list, since those drugs are subsidized by the National Health Fund (NFZ) and doctors most often prescribe drugs from the list. The new list will enter into effect on February 1.
3. (C) Eli Lilly’s Zyprexa was added to the list. Lilly had requested USG assistance in communicating with the Health Ministry regarding their application to put Zyprexa on the list. Concerta, a treatment for attention deficit disorder produced by a Johnson & Johnson subsidiary, was also added to the list. Concerta alone will cost the NFZ about PLN 26 million per year (about USD 8.6 million).
4. (SBU) U.S. pharmaceuticals company contacts told EconOff that sales of some of their products already on the list will benefit from having co-payments reduced or eliminated. Furthermore, 24 “combination” products” — one pill comprised of two substances already on the list — were added. Such combinations may be preferred by patients and doctors, and are more challenging to manufacture thus potentially giving U.S. innovative producers an edge.
5. (U) Prices were cut for 16 drugs, 202 generics were added to the list, and 65 products no longer available on the Polish market were removed. The government also extended coverage for innovative treatments of four rare diseases. Treating an estimated 195 patients per year with those diseases will cost PLN 41.6 million (about USD 14 million). All in all, the changes to the reimbursement list will increase the state’s health care costs by about PLN 250 million (about USD 83 million) per year.
6. (SBU) While the list brought some companies good news, they continue to voice serious concerns about transparency and access to the Ministry. Company officials point out that it is unclear why the Ministry approved treatments for some conditions and not others. Furthermore, the list was released without warning over the New Year’s holiday, with public comments due January 7. Since many employees were on vacation, this left companies scrambling to analyze the list and compile comments in time.
7. (SBU) A roster of meeting requests on the Ministry’s website confirms industry complaints that it takes four or five months to arrange a meeting. Industry members are not the only ones having difficulty with access to the Minsitry; post requested a meeting to discuss this and other transparency issues over two months ago, but has yet to receive a response, despite regular prodding. Lack of access to the Ministry extends beyond issues regarding pharmaceuticals. For example, post received a response on January 8 to a demarche it had delivered six months earlier regarding conferences on innovation, cost conservation and emergency medical responses. By the time the response was received, the proposed date for the conferences was long past.
8. (SBU) The Ministry’s apparent disdain for consultations with corporate stakeholders has led to policy measures — such as recent restrictions on pharmaceuticals advertising and sales calls — that industry assert unduly disrupt established business plans and investments. In this vein, numerous contacts (including some in the government) have told EconOff the Ministry is preparing to introduce a measure to fix profit margins on pharmaceutical products, an idea industry strongly opposes. WARSAW 00000046 002.2 OF 002
9. (C) Industry officials also continue to be troubled by the role of the Health Technology Assessment Agency (HTA). Polish law allows the Minister to request a cost-benefit analysis from the HTA. In 2008, the Ministry began doing this for all innovative drugs. HTA’s Deputy Director, Zbigniew Krol, told EconOff that the Agency struggled to find qualified employees, but now has a staff of about 50. The lack of staff and crush of work prevented the HTA from taking meetings with industry, which could be time consuming but provide little informational value. Furthermore, the HTA provides its services to the Ministry pursuant to a contract, and consequently does not see itself as a “partner for collaborating with companies.” In fact, until October 2008 the Ministry of Health prohibited HTA staff from having direct contact with pharmaceutical companies. Krol stated that HTA’s agreement with the Ministry calls for assessments to be completed within 180 days, and the agency’s goal is actually to finish within six weeks. However, Krol acknowledged, a number of dossiers — maybe 15 percent — are delayed. Several contacts in the Polish government have hinted that the HTA’s processes may be formalized in regulation in 2009. Also, companies would rather see their drug applications held up for further review by HTA than to have the HTA expeditiously issue a negative recommendation. Nevertheless, the HTA has become a key gatekeeper in the reimbursement process, and complaints about it being a “black box” appear justified. ASHE