Canada Denies Public Access To Potentially Life-Prolonging Ovarian Cancer Treatment LYNPARZA® (olaparib)

Pan-Canadian Oncology Drug Review (pCODR) Decides not to Recommend Lynparza for Reimbursement

MISSISSAUGA, ON, Oct. 5, 2016 /CNW/ - Following its deliberations, the pan-Canadian Oncology Drug Review (pCODR) recently announced its decision not to recommend for provincial reimbursement, Lynparza (olaparib), a maintenance treatment for women with platinum-sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer. AstraZeneca Canada is extremely disappointed that pCODR has disregarded the demonstrated significant clinical benefits of Lynparza, including potentially prolonging life, creating a roadblock for Canadian women in accessing the first oral, targeted therapy for BRCA-mutated relapsed ovarian cancer. 

"We are surprised and deeply disappointed in pCODR's assessment of Lynparza," says Mark Findlay, Vice President, Patient Access & Established Brands, AstraZeneca Canada. "Regulatory bodies around the world, Canadian oncologists and patient organizations have all demonstrated strong support for this important advancement in ovarian cancer treatment. Additionally, women from many countries with similar reimbursement agencies as pCODR, such as the UK, France, Norway, Denmark and Sweden, already have access to this treatment option as a result of reimbursement of Lynparza; Canadian women deserve no less. We are committed to working with provincial governments to urgently address the issue of access to Lynparza for Canadian women with relapsed ovarian cancer."

In its assessment, pCODR questioned the clinical benefits of Lynparza, despite Health Canada, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and many regulatory bodies around the world having assessed and approved Lynparza based on its efficacy and safety data. Lynparza was first approved by the FDA in 2014 following an accelerated approval. Since then, more than 45 countries have approved Lynparza, several of which have also provided accelerated approval.¹ The pCODR recommendation not to list means that, for many Canadian women, it will be more difficult to receive coverage for a medicine that has been reimbursed and available to patients in many countries since 2014. Canadian women with ovarian cancer are at a distinct disadvantage, as Canada is now falling behind emerging economies, including Greece, Romania, Hungary and Poland, when it comes to providing public funding for this innovative, targeted therapy.²

Only effective treatment option for BRCA-mutated ovarian cancer
Approved by Health Canada earlier this year, Lynparza is the first and only PARP (poly ADP-ribose polymerase) inhibitor available and is indicated as maintenance treatment, prolonging the interval to next chemotherapy for patients with platinum-sensitive relapsed BRCA-mutated ovarian cancer. Lynparza has been shown to provide women with almost a year of life without progressive disease and the need for subsequent treatment with chemotherapy, versus only four months for those who do not receive treatment with Lynparza.³ An improvement in overall survival of 4.7 months has also been demonstrated by Lynparza (median overall survival data was 34.9 months for Lynparza and 30.2 for placebo).⁴ As an oral medication, patients are able to take it in the comfort of their home, reducing hospital visits, and delaying the need for women to receive treatment with chemotherapy, which can cause unpleasant side effects.⁵

Rapid public access remains crucial
Patients with a BRCA mutation who have platinum-sensitive relapsed ovarian cancer have significant disease burden and a lack of treatment options. Treatment with Lynparza can make a meaningful difference for many of these women, potentially extending life while leading to fewer side effects compared with chemotherapy. Each day that women in need are denied access to treatment, more patients will experience disease progression and more lives will be lost to this devastating disease.

Provincial governments have the opportunity to provide access to Lynparza now for women suffering from ovarian cancer, rather than denying patients access to this potentially life-prolonging treatment. AstraZeneca is committed to working with the pan-Canadian Pharmaceutical Alliance, the provinces and private payers to ensure Canadian women have access to this innovative, targeted therapy as soon as possible.

"Ovarian cancer affects hundreds of Canadian women in the prime of their lives. There are very limited treatment options available to women living with advanced BRCA-mutated ovarian cancer, which makes urgent access to new options critical," says Dr. Michael Fung-Kee-Fung, Head Surgical Oncology Program, the Ottawa Regional Cancer Centre, Professor, Department Obstetrics and Gynecology, Department of Surgery, University of Ottawa. "It is very disappointing to learn that, due to this decision, some women with this disease will be forced to wait to gain public access to a treatment that could prolong and improve their lives. PARP inhibitors, such as olaparib, remain one of the most promising classes of drugs presently available for this unique segment of ovarian cancer patients. It is imperative that every effort be made to reduce barriers to appropriate access."

About Lynparza^® (olaparib)
Lynparza is a first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. It is the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer. Health Canada's Notice of Compliance with Conditions for Lynparza follows the announcement of the approval of Lynparza by the FDA on December 19, 2014 and in the European Union on December 18, 2014. AstraZeneca is conducting multiple Phase III studies across a variety of indications and tumour types for Lynparza.

Lynparza is a trademark of the AstraZeneca group of companies.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of primary and specialty care medicines that transform lives. Our primary focus is on three important areas of healthcare: Cardiovascular and Metabolic disease; Oncology; and Respiratory, Inflammation and Autoimmunity. AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. In Canada, we employ more than 675 employees across the country and our AstraZeneca Canada headquarters are located in Mississauga, Ontario. For more information, please visit the company's website at www.astrazeneca.ca.

REFERENCES:
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¹ AstraZeneca Feedback on pERC Initial Recommendation. Lynparza (olaparib) for PSR BRCAm Ovarian Cancer, on file.
² Lynparza^® Reimbursement Summary. On file.
³ Lynparza^® (olaparib) Product Monograph. Accessed October 3, 2016. Available at: http://www.astrazeneca.ca/cs/BlobServer?blobcol=pdffile&blobheader=application%2Fpdf&blobheadername1=Content-Disposition&blobheadername2=MDT-Type&blobheadervalue1=inline%3B+filename%3DLYNPARZA-Product-Monograph-EN.pdf&blobheadervalue2=abinary%3B+charset%3DUTF-8&blobkey=id&blobnocache=true&blobtable=AZ_FixedURLPDF&blobwhere=1285591055966&ssbinary=true ⁴ Jonathan A. Ledermann. ASC University. Overall survival (OS) in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC) receiving olaparib maintenance monotherapy: An interim analysis. Accessed September 30, 2016. On file. Abstract available at: http://meetinglibrary.asco.org/content/166142-176
⁵ Canadian Cancer Society. Side effects of chemotherapy. Accessed September 30, 2016. Available at: http://www.cancer.ca/en/cancer-information/diagnosis-and-treatment/chemotherapy-and-other-drug-therapies/chemotherapy/side-effects-of-chemotherapy/?region=bc

SOURCE AstraZeneca Canada Inc.

CONTACTS: Lisa Cancian, Account Supervisor, Healthcare, Weber Shandwick, Tel: [phone], E-mail: [email protected]; Michelle Marchione, Senior Manager, Corporate Communications, AstraZeneca Canada, Tel: [phone], Email: [email protected]