Lenalidomide added to the Essential Medicines List

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The Cancer Alliance and multiple myeloma patients are celebrating the win of lenalidomide finally included on the Essential Medicines List for the public sector.

The Cancer Alliance launched its Access to Medicine campaign on World Cancer Day, 4 February 2018, after the landmark report Exploring Patent Barriers to Cancer Treatment Access in South Africa: 24 Medicine Case Studies was published in 2017. 

From the 24 medicines, a list of eight medicines were selected as a dedicated focus for equitable access. Lenalidomide was one of the medicines included. This medicine is used for the treatment of multiple myeloma. 

In 2019, a total of 414 cases were reported to the National Cancer Registry (NCR). This is likely an underestimate of the true incidence of this cancer in South Africa as only cases diagnosed with a bone marrow test are reported to the NCR.  

History of lenalidomide

Lenalidomide is only one of the medicines used for the treatment of multiple myeloma. It is a derivative of thalidomide, the medicine that was recalled in 1958 for causing birth defects and was then patented (again) by a pharmaceutical company when it was discovered that it could be used for the treatment of cancer. The pharmaceutical company registered their first patent in 1996 and a subsequent 117 patents thereafter. The primary patent expired in 2019. 

Before 2016 this medicine was only available in South Africa as a Section 21 authorised medicine, which meant that patients had to have permission from the then Medicines Control Council to import it. At the time the originator as well as a generic product from India was available at an affordable price of less than R5 000 for a month’s treatment cycle. 

In 2016, the originator product was registered with a new pharmaceutical company as the supplier, and the pricing changed from less than R5 000 per month to R75 000 for a month’s treatment. There was no way the majority of patients in the private sector could afford this, with most medical schemes denying access or with heavy co-payments. Patients in the public sector were completely excluded. 

Sue Johnson’s story

The Cancer Alliance became aware of this case with Sue Johnson’s story and started to pursue the journey for equitable and affordable access to lenalidomide. The first hurdle was to appeal for continued access for patients that already had access. This right had been established with HIV medicine access and was then used in the case that was taken on appeal. 

Access for those previously on the Section 21 approved lenalidomide was granted in 2017, thus reconfirming a major legal principle. 

Generic approvals

Various companies submitted dossiers for the approval of generic lenalidomide with the five of these approved by July 2020. 

The pharmaceutical company that was registered as the supplier in 2016 then registered the third derivative, pomalidomide, in August 2020, with a single exit price (SEP) of R83 895 after losing their lenalidomide market to the generic companies. 

The initial pricing for generic lenalidomide started at R 20 474 for a month’s supply of 25mg capsules. Competition between the companies stimulated a healthy ‘price war’ with the current price varying between R6 845, 55 and R8 294. 

WHO’s model essential medicines list

In 2019, the World Health Organization added lenalidomide to its model essential medicines list. The Cancer Alliance advocated to the National Department of Health (NDoH) for the inclusion of lenalidomide. We even protested at the WHO Pricing Forum event in Johannesburg about the unaffordability of this vital medicine. 

Unfortunately, lenalidomide could not be added to the South African Essential Medicines List due to the high cost of the generic versions available. 

Finally added to Essential Medicines List

In December 2022, the NDoH, after a considerable price drop and safety considerations, added lenalidomide to the Essential Medicines List for all newly diagnosed multiple myeloma patients. This means that current patients on thalidomide treatment will continue with their treatment until the contract with the pharmaceutical company for thalidomide expires in June 2024. Lenalidomide will then be added to the new tender list that will be advertised later in 2023 for the 2024-2026 contract period. 

This achievement has the further implication that lenalidomide should now be regarded as a Prescribed Minimum Benefit by medical schemes. This will improve out-of-pocket expenditure for patients in the private sector. 

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