Chronic Disease Fund Integrity Agreement

cdF Travel Fund for Multiple Myeloma for Onyx. In July 2012, Onyx (now owned by Amgen) received approval to market Kyprolis as a third-line treatment for multiple myeloma. Kyprolis must be infected in a health facility. Around the time of authorization, Onyx asked CDF to create a fund that would cover the travel expenses of patients taking a multiple myeloma drug. At Onyx`s request, CDF created the fund, which Onyx financed alone. Internally, CDF sometimes referred to the fund as “Kyprolis Travel” and, in fact, it operated primarily to cover the travel expenses of patients who took Kyprolis. At the same time as the FCA`s claims settlement, Novartis entered into a company agreement with the Department of Health and Human Services Office of Inspector General (HHS-OIG). Among other things, the CIA requires Novartis to significantly reduce its paid spokesperson programs and the amount spent on programs. In addition, remaining spokesperson programs can only occur in limited circumstances (can only occur within 18 months of FDA approval of a new state-reimbursed product or a new indication for a previously FDA approved product) and in a virtual format (outside spokespeople must be remote and must not be in the same location as a bystander).

In addition, there is a $100,000 total speaking and speaking pay limit of $10,000 and a total compensation limit of $10,000 per speaker (excluding Novartis` direct payments for travel and travel expenses). In separate statements, neither organization mentioned the financial terms of the transaction. Dan Klein, president of panF and CEO, said the agreement does not, in part, address ongoing operations or sickness funds, which are subject to an annual review by an independent audit organization to comply with the OIG`s guidelines and their opinion. CdF ARI Co-pay Fund for Astellas. Xtandi, an astellas product, is indicated for the treatment of mCRPC in patients with failed chemotherapy. Following the launch of Xtandi in September 2012, Astellas provided funding for the mCRPC fund to CDF. Xtandi is an androgen receptor inhibitor (“ARI”); None of the other major mCRPC drugs are ARI. In May 2013, Astellas contacted CDF to request the opening of an ARI fund that would cover MCRPC patients` supplements for REBAs, but not for other mCRPC drugs. CDF knew that this meant that Astellas was trying to get money for Xtandi patients and not for others, because Xtandi was the dominant ARI drug for the treatment of mCRPC. On July 1, 2013, CDF opened an ARI fund at the request of Astellas.

Astellas alone financed the CDF`s ARI fund. As CDF predicted, Xtandi patients received almost all of the money the fund paid. CdF PNET Co-pay Fund for Novartis. In May 2011, Afinitor, a novartis product, was approved for the treatment of pancreatic progressive neuroendocrine tumours (“PNTs”). In 2012, Novartis asked CDF to open a co-payment fund to cover Afinitor-Co-Pays for PNET patients. At that time, CDF knew that Sutent, a pfizer drug, was also authorized for the treatment of PNET. In August 2012, at the request of Novartis, CDF opened a so-called “PNET” fund. The fund financed by Novartis alone covered only Pouritor; It did not cover supplements for Sutent, the other authorized PNET drug. PANF Prostate Cancer Sub-Fund. In March 2010, PANF opened a fund covering supplements for patients who were taking a drug for the treatment of prostate cancer. .

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