Photo courtesy of CDC
England’s National Health Service (NHS) plans to remove several drugs used to treat hematologic malignancies from the Cancer Drugs Fund (CDF).
The plan is that, as of November 4, 2015, pomalidomide, lenalidomide, ibrutinib, dasatinib, brentuximab, bosutinib, and bendamustine will no longer be funded via the CDF for certain indications.
Ofatumumab was removed from the CDF list yesterday but is now available through the NHS.
Drugs used to treat solid tumor malignancies are set to be de-funded through CDF in November as well.
However, the NHS said the proposal to remove a drug from the CDF is not necessarily a final decision.
In cases where a drug offers enough clinical benefit, the pharmaceutical company developing that drug has the opportunity to reduce the price they are asking the NHS to pay to ensure that it achieves a satisfactory level of value for money. The NHS said a number of such negotiations are underway.
In addition, patients who are currently receiving the drugs set to be removed from the CDF will continue to have access to those drugs.
About the CDF and the NHS
The CDF—set up in 2010 and currently due to run until March 2016—is money the government has set aside to pay for cancer drugs that haven’t been approved by the National Institute for Health and Care Excellence (NICE) and aren’t available within the NHS in England. Most cancer drugs are routinely funded outside of the CDF.
NHS England and NICE are planning to consult on a proposed new system for commissioning cancer drugs. The NHS said the new system will be designed to provide the agency with a more systematic approach to getting the best price for cancer drugs.
Reason for drug removals
The NHS previously increased the budget for the CDF from £200 million in 2013/14, to £280 million in 2014/15, and £340 million from April 2015. This represents a total increase of 70% since August 2014.
However, current projections suggest that spending would rise to around £410 million for this year, an over-spend of £70 million, in the absence of further prioritization. The NHS said this money could be used for other aspects of cancer treatment or NHS services for other patient groups.
Therefore, some drugs are set to be removed from the CDF. The NHS said all decisions on drugs to be maintained in the CDF were based on the advice of clinicians, the best available evidence, and the cost of the treatment.
“There is no escaping the fact that we face a difficult set of choices, but it is our duty to ensure we get maximum value from every penny available on behalf of patients,” said Peter Clark, chair of the CDF.
“We must ensure we invest in those treatments that offer the most benefit, based on rigorous evidence-based clinical analysis and an assessment of the cost of those treatments.”
While de-funding certain drugs will reduce costs, the CDF is not expected to be back on budget this financial year. The NHS does expect the CDF will be operating within its budget during 2016/17.
Blood cancer drugs to be removed
The following drugs are currently on the CDF list for the following indications, but they are set to be de-listed on November 4, 2015.
Bendamustine
For the treatment of chronic lymphocytic leukemia (CLL) where all the following criteria are met:
- Application made by and first cycle of systemic anticancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anticancer therapy
- CLL (not licensed in this indication)
- Second-line indication, third-line indication, or fourth-line indication
- To be used within the treating Trust’s governance framework, as bendamustine is not licensed in this indication
For the treatment of relapsed mantle cell lymphoma (MCL) where all the following criteria are met:
- Application made by and first cycle of systemic anticancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anticancer therapy
- MCL
- Option for second- or subsequent-line chemotherapy
- No previous treatment with bendamustine
- To be used within the treating Trust’s governance framework, as bendamustine is not licensed in this indication
*Bendamustine will remain on the CDF for other indications.
Bosutinib
For the treatment of refractory, chronic phase chronic myeloid leukemia (CML) where all the following criteria are met:
- Application made by and first cycle of systemic anticancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anticancer therapy
- Chronic phase CML
- Refractory to nilotinib or dasatinib (if dasatinib accessed via a clinical trial or via its current approved CDF indication)
For the treatment of refractory, accelerated phase CML where all the following criteria are met:
- Application made by and first cycle of systemic anticancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anticancer therapy
- Accelerated phase CML
- Refractory to nilotinib or dasatinib (if dasatinib accessed via a clinical trial or via its current approved CDF indication)
- Significant intolerance to nilotinib (grade 3 or 4 events)
For the treatment of accelerated phase CML where there is intolerance of treatments and where all the following criteria are met:
- Application made by and first cycle of systemic anticancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anticancer therapy
- Accelerated phase CML
- Significant intolerance to dasatinib (grade 3 or 4 adverse events; if dasatinib accessed via its current approved CDF indication)
- Significant intolerance to nilotinib (grade 3 or 4 events)
*Bosutinib will still be available through the CDF for patients with chronic phase CML that is intolerant of other treatments.
Brentuximab
For the treatment of refractory, systemic anaplastic lymphoma where all the following criteria are met:
- Application made by and first cycle of systemic anticancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anticancer therapy
- Relapsed or refractory systemic anaplastic large-cell lymphoma
For the treatment of relapsed or refractory CD30+ Hodgkin lymphoma where all the following criteria are met:
- Application made by and first cycle of systemic anticancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anticancer therapy
- Relapsed or refractory CD30+ Hodgkin lymphoma
- Following autologous stem cell transplant or following at least 2 prior therapies when autologous stem cell transplant or multi-agent chemotherapy is not an option
Dasatinib
For the treatment of Philadelphia-chromosome-positive (Ph+) acute lymphoblastic leukemia where all the following criteria are met:
- Application made by and first cycle of systemic anticancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anticancer therapy
- Refractory or significant intolerance or resistance to prior therapy including imatinib (grade 3 or 4 adverse events)
- Second-line indication or third-line indication
*Dasatinib will still be available for chronic phase and accelerated phase CML.
Ibrutinib
For the treatment of relapsed/refractory CLL where all the following criteria are met:
- Application made by and first cycle of systemic anticancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anticancer therapy
- Confirmed CLL
- Must have received at least 1 prior therapy for CLL
- Considered not appropriate for treatment or retreatment with purine-analogue-based therapy due to:
- Failure to respond to chemo-immunotherapy or
- A progression-free interval of less than 3 years or
- Age of 70 years or more or
- Age of 65 years or more plus the presence of comorbidities or
- A 17p or TP53 deletion
- ECOG performance status of 0-2
- A neutrophil count of ≥0.75 x 10⁹/L
- A platelet count of ≥30 x 10⁹/L
- Patient not on warfarin or CYP3A4/5 inhibitors
- No prior treatment with idelalisib
For the treatment of relapsed/refractory MCL where all the following criteria are met:
- Application made by and first cycle of systemic anticancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anticancer therapy
- Confirmed MCL with cyclin D1 overexpression or translocation breakpoints at t(11;14)
- Failure to achieve at least partial response with, or documented disease progression disease after, the most recent treatment regimen
- ECOG performance status of 0-2
- At least 1 but no more than 5 previous lines of treatment
Lenalidomide
For the second-line treatment of multiple myeloma (MM) where all the following criteria are met:
- Application made by and first cycle of systemic anticancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anticancer therapy
- MM
- Second-line indication
- Contraindication to bortezomib or previously received bortezomib in the first-line setting
*Lenalidomide will still be available for patients with myelodysplastic syndromes with 5q deletion.
Pomalidomide
For the treatment of relapsed and refractory MM where the following criteria are met:
- Application made by and first cycle of systemic anticancer therapy to be prescribed by a consultant specialist specifically
- MM
- Performance status of 0-2
- Previously received treatment with adequate trials of at least all of the following options of therapy: bortezomib, lenalidomide, and alkylating agents
- Failed treatment with bortezomib or lenalidomide, as defined by: progression on or before 60 days of treatment, progressive disease 6 months or less after achieving a partial response, or intolerance to bortezomib
- Refractory disease to previous treatment
- No resistance to high-dose dexamethasone used in the last line of therapy
- No peripheral neuropathy of grade 2 or more
A complete list of proposed changes to the CDF, as well as the drugs that were de-listed on March 12, 2015, is available on the NHS website.
