Brief Summary: This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer. This program is designed to provide access to niraparib prior to approval by the US Food and Drug Administration (FDA).
Full Answer
What is the Expanded Access program for niraparib?
This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer. This program is designed to provide access to niraparib prior to approval by the US Food and Drug Administration (FDA).
How do I get access to niraparib?
It will be available through the Cancer Drugs Fund until then. There is a managed access agreement, which includes a patient access scheme and a commercial access agreement for niraparib. Contact [email protected] for details.
How can non-NHS organisations get support with niraparib?
Non-NHS organisations can contact [email protected] for details. This guidance updates and replaces NICE technology appraisal guidance 528 on niraparib for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer which was available through the Cancer Drugs Fund.
What is niraparib used to treat?
Niraparib (Zejula ®) is a targeted therapy drug. It is used to treat some types of ovarian, fallopian tube or primary peritoneal cancer. What is Niraparib? When is niraparib given?
Is niraparib available on NHS?
The company has a commercial arrangement. This makes niraparib available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.
Is niraparib covered by Medicare?
Yes. 100% of Medicare prescription drug plans cover this drug.
How much does Zejula cost per month?
Zejula Coupon & Prices - Cost $49 per month.
Can you drink alcohol with niraparib?
The drinking of alcohol (in small amounts) does not appear to affect the safety or usefulness of niraparib. Niraparib may affect fertility in men. If you plan to have children, discuss this with your doctor before being treated with niraparib. Niraparib may damage sperm and may harm the baby if used during pregnancy.
Does Medicare pay for Zejula?
Do Medicare prescription drug plans cover Zejula? Yes. 100% of Medicare prescription drug plans cover this drug.
Are PARP inhibitors covered by insurance?
Conclusions: Although insurers are responsible for a large proportion of PARP inhibitor costs, out-of-pocket costs for PARP inhibitors account for a majority of patients' drug spending.
How long do you stay on Zejula?
*In a first-line maintenance clinical trial, ZEJULA delayed disease progression for a median of 14 months vs 8 months with placebo. Results may vary. The trial is ongoing to see if patients live longer overall with treatment.
Does Zejula slow hair growth?
If you develop high blood pressure during Zejula treatment, your doctor may prescribe a blood pressure medication for you. Or they may adjust your dosage of Zejula. In clinical studies, hair loss wasn't reported as a side effect of Zejula. So the drug isn't thought to cause hair loss.
How long do you have to take Zejula?
Treatment with ZEJULA requires routine monitoring. Your healthcare provider will do blood tests to check your blood cell counts before treatment with ZEJULA, weekly for the first month of treatment with ZEJULA, monthly for the next 11 months, then as needed during treatment with ZEJULA.
Does Zejula prolong life?
The PARP inhibitor Zejula is a precision cancer medicine that delays ovarian cancer progression and prolongs survival.
How effective is niraparib?
For the overall study population, 84% who received niraparib were still alive at 2 years compared with 77% who received placebo. For patients with homologous recombination deficiency, 91% who received niraparib were still alive at 2 years compared with 85% who received placebo.
Can you take paracetamol with niraparib?
Interactions between your drugs No interactions were found between niraparib and Paracetamol.
What drugs are not covered by Medicare?
Medicare does not cover:Drugs used to treat anorexia, weight loss, or weight gain. ... Fertility drugs.Drugs used for cosmetic purposes or hair growth. ... Drugs that are only for the relief of cold or cough symptoms.Drugs used to treat erectile dysfunction.More items...
Does Medicare Part B cover chemotherapy drugs?
Medicare Part B usually covers 80% of outpatient cancer-related services, such as radiation therapy and chemotherapy, after a $203 deductible. The insured person is responsible for paying the remaining 20% of the costs.
Is there a generic available for Zejula?
No. There is currently no therapeutically equivalent version of Zejula available in the United States. Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zejula.
Does Medicare Part D cover biologics?
Biologics—usually large, complex molecules produced in a living system—are some of the most expensive drugs available, and spending for biologics is growing in Medicare Part D because they treat diseases common among Medicare beneficiaries. Biologics are estimated to cost Part D upwards of $12 billion annually.
How to take Niraparib?
Try to take the capsules at the same time each day. Feeling sick can be a side effect of niraparib. Taking your capsules at bedtime may help control sickness. Swallow the capsules whole with water. Do not chew, dissolve or open them. If you forget to take the capsules, do not take a double dose. Take your next dose at the usual time and let your doctor or nurse know.
When is niraparib given?
Your cancer doctor can tell you if it is appropriate for you. Some people may be given it as part of a research trial and sometimes for other cancer types.
Can niraparib be taken with painkillers?
Some medicines can affect niraparib or be harmful when you are having it. This may include common medicines such as some painkillers and antibiotics. Always ask your cancer doctor about any drugs you are taking, including:
Can you take niraparib at home?
Niraparib is given as capsules. This means you can take it at home. Niraparib can reduce the number of blood cells in your blood. You will have regular blood tests during your treatment. If your blood cell levels get too low, your doctor may tell you to stop taking niraparib for a short time until this improves.
What is the role of commissioners in the NHS?
Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Is there a managed access agreement for Niraparib?
There is a managed access agreement, which includes a patient access scheme and a commercial access agreement for niraparib. Contact [email protected] for details.
Is this guidance up to date?
After this NICE will decide whether or not to recommend it for use on the NH S and update the guidance. It will be available through the Cancer Drugs Fund until then.
What is a patient access scheme?
Patient access schemes: A patient access scheme is a scheme proposed by a pharmaceutical company in order to improve the cost-effectiveness of a medicine and enable patients to receive access to cost-effective innovative medicines. A Patient Access Scheme Assessment Group (PASAG), established under the auspices of NHS National Services Scotland reviews and advises NHSScotland on the feasibility of proposed schemes for implementation. The PASAG operates separately from SMC in order to maintain the integrity and independence of the assessment process of the SMC. When SMC accepts a medicine for use in NHSScotland on the basis of a patient access scheme that has been considered feasible by PASAG, a set of guidance notes on the operation of the scheme will be circulated to Area Drug and Therapeutics Committees and NHS Boards prior to publication of SMC advice.
Is niraparib a PARP inhibitor?
Niraparib is an orally administered, highly selective poly (adenosine diphosphate-ribose) polymerase (PARP) -1 and -2 inhibitor exhibiting potent anti -tumour activity through the direct inhibition of PARP. The cytotoxicity of niraparib was observed in tumour cells regardless of the presence of deficiencies in the breast cancer tumour suppressor genes BRCA1/2. Niraparib is already accepted for restricted use in NHSScotland as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy, restricted to patients who do not have a germline BRCA mutation (SMC1341/18). Niraparib has recently received marketing authorisation for earlier maintenance treatment for patients in response after first-line platinum-based chemotherapy.1, 2
Is Niraparib monotherapy?
The company submitted a cost-utility analysis of niraparib against routine surveillance as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. The base case analysis was based on the ITT population from the PRIMA study, with additional analysis performed to capture the broader population captured by the marketing authorisation. The company also provided an exploratory cost-minimisation analysis versus olaparib in the BRCA mutation subgroup.
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