On 10 February 2025, the Scottish Medicines Consortium (SMC) issued its February 2025 decisions on medicines for reimbursement by NHS Scotland, including accepting three biologics and rejecting another.

AstraZeneca’s Imfinzi® (durvalumab) will be reimbursed for use in combination with chemotherapy for the treatment of adults with newly diagnosed extensive-stage small cell lung cancer.  This follows recommendation of the combination therapy by UK’s NICE in January 2025.  Regeneron and Sanofi’s Libtayo® (cemiplimab) has also been accepted for reimbursement by the SMC for the treatment of adults with recurrent or metastatic cervical cancer, where the cancer has progressed on or after chemotherapy.

AstraZeneca and MSD’s Lynparza® (olaparib) was accepted for the treatment of adults with BRCA1 or 2 mutated HER2-negative advanced breast cancer, who have already received appropriate treatments for their type of breast cancer.  In December 2024, AstraZeneca and MSD announced positive results for Lynparza® in the treatment of breast cancer, demonstrating a reduced risk of death by 28%.

However, the SMC did not recommend reimbursement of Eisai and Biogen’s Leqembi® (lecanemab) for treating early-stage Alzheimer’s disease in adults who carry one or no copies of a gene called ApoE4.  The committee cited uncertainties surrounding the drug’s clinical benefits and concerns about its cost-effectiveness, but has invited a resubmission addressing those uncertainties.

The rejection follows a similar decision by the UK’s NICE in August 2024, which found that the benefits of lecanemab were too small to warrant making the drug available on the NHS.  On 28 January 2025, the European Commission asked the Committee for Medicinal Products for Human Use (CHMP) to re-consider the positive opinion granted to Leqembi® in November 2024 for early Alzheimer’s disease following safety information that has since become available.

On 20 December 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its November 2024 meeting.

The following biosimilars were recommended for listing on the Pharmaceutical Benefits Scheme (PBS):

• Sandoz’s Wyost®, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab), for osteoporosis, giant cell tumour of bone, and bone metastases
• Celltrion’s Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), for severe chronic plaque psoriasis, severe psoriatic arthritis, Crohn’s disease, complex refractory fistulising Crohn’s disease, and moderate to severe ulcerative colitis.

Among the originator biopharmaceuticals, Bayer secured a recommendation for its Eylea® (aflibercept) indication expansion for diabetic macular oedema and subfoveal choroidal neovascularisation secondary to age-related macular degeneration.  Novo Nordisk’s Ozempic® (semaglutide) also received a positive recommendation for type 2 diabetes mellitus, following its application for a new strength formulation.

Several oncology treatments received positive recommendations, including Janssen’s Rybrevant® (amivantamab) for non-small cell lung cancer.  Other cancer treatments recommended include Amgen’s Blincyto® (blinatumomab) for MRD-negative B-cell precursor acute lymphoblastic leukaemia, AstraZeneca’s Imfinzi® for use in combination with platinum-based chemotherapy for the treatment of deficient mismatch repair (dMMR) endometrial cancer, and Astellas Pharma’s Padcev® (enfortumab vedotin) for locally advanced or metastatic urothelial cancer.

AbbVie’s Epkinly® (epcoritamab) received a recommendation for relapsed or refractory diffuse large B-cell lymphoma, while Novartis’ Aimovig® (erenumab) was recommended for chronic migraine.

For hereditary angioedema, both CSL’s garadacimab and Takeda’s Takhzyro® (lanadelumab) secured positive recommendations.

Additional recommendations were granted to BMS’s Opdivo® (nivolumab) for urothelial carcinoma, MSD’s Keytruda® (pembrolizumab) for renal cell carcinoma, and Alexion Pharmaceuticals’ Ultomiris® (ravulizumab) for Neuromyelitis Optica Spectrum Disorder.

BeiGene’s Tevimbra® (tislelizumab) also received a positive recommendation for oesophageal squamous cell carcinoma.

The PBAC reports that some earlier recommendations have been extended:

• Sanofi’s Dupixent® (dupilumab) for chronic severe atopic dermatitis and uncontrolled severe asthma

Additionally, two recommendations have been rescinded:

• Celltrion Remsima SC® (infliximab) for rheumatoid arthritis
• AbbVie’s Skyrizi® (risankizumab) for Crohn’s disease

On 11 December 2024, AstraZeneca and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the US and Canada) announced positive results for Lynparza® (olaparib) in the treatment of breast cancer, as demonstrated in the OlympiA Phase III trial presented at the San Antonio Breast Cancer Symposium 2024.  

Lynparza® reduced the risk of death by 28% (hazard ratio [HR]: 0.72).  In addition, 87.5% of patients treated with Lynparza were alive at six years vs. 83.2% in the comparator arm.  

Lynparza demonstrated a 35% reduction in invasive disease recurrence, second cancers, or death (HR: 0.65) and a 35% reduction in distant disease recurrence or death (HR: 0.65). 

The benefits spanned all key patient subgroups, including those with high-risk, hormone-receptor-positive disease. 

This news follows AstraZeneca’s recent approval to market Lynparza® in India in combination with durvalumab for the maintenance treatment of advanced or recurrent endometrial cancer (November 2024), and reaffirms Lynparza® as the first and only PARP inhibitor to improve overall survival (OS) in early-stage, high-risk, HER2-negative breast cancer with BRCA mutations. 

On 26 November 2024, The Economic Times reported that AstraZeneca has received approval from India’s Central Drugs Standard Control Organisation (CSDCO) to market Lynparza® (olaparib) in India.  

The CDSCO granted approval for the use of Lynparza® in combination with durvalumab for the maintenance treatment of advanced or recurrent endometrial cancer in adults whose disease has not progressed on first-line platinum-based chemotherapy.  Lynparza® received Indian approval in August 2022 as a monotherapy for adjuvant treatment of patients with high-risk early breast cancer. 

This follows European approval of the combination treatment in August 2024.  AstraZeneca confirmed in August 2024 that regulatory submissions for Imfinzi® and Lynparza® were (then) under review in Japan and several other countries. 

On 23 August 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its July 2024 meeting, recommending listing for one biosimilar, and three originator biopharmaceuticals.

The following biosimilars were recommended for listing on the Pharmaceutical Benefits Scheme (PBS):

• Sandoz’s Hyrimoz® (adalimumab) for the same indications as the currently PBS-listed reference biologic, Abbvie’s Humira®, and other brands of adalimumab.

In addition, the following originator biopharmaceuticals were recommended for PBS listing:

• Roche’s Vabysmo® (faricimab) for the treatment of retinal vein occlusion.
• AstraZeneca’s Lynparza® (olaparib) for the treatment of HER2-negative metastatic breast cancer for patients with a confirmed BRCA1 or BRCA2 mutation.
• Takeda’s Entyvio® (vedolizumab) for continuing treatment of chronic pouchitis.

PBAC reports that MSD’s Keytruda® (pembrolizumab) solution concentrate for IV infusion 100 mg in 4 mL has had its May 2022 recommendation extended for an additional 12 months.  Janssen’s Stelara® (ustekinumab) injection 90 mg in 1 mL pre-filled syringe has had its July 2022 recommendation rescinded.

In August 2024, we reported that a number of biopharmaceuticals and biosimilars are potentially in line for September listings on the PBS, including two biosimilars to Abbvie’s Humira® (adalimumab): Organon’s Hadlima® (adalimumab-bwwd) in 40 mg/0.4 ml PFP and Celltrion’s Yuflyma® (adalimumab-aaty) in 0.8 mg/0.8 ml PFN and PFS.

AstraZeneca has announced that its Imfinzi® (durvalumab) and Lynparza® (olaparib) combination has been approved in the EU as treatment for certain patients with primary advanced or recurrent endometrial cancer.  This approval follows the recommendation by the EMA’s Committee for  Medicinal Products for Human Use (CHMP), which was based on DUO-E Phase II results last month.

AstraZeneca’s report also mentions that regulatory submissions for Imfinzi® and Lynparza® are currently under review in Japan and several other countries based on the DUO-E trial.  The FDA also recently approved Imfinzi® (durvalumab) plus chemotherapy for dMMR patients with primary advanced or recurrent endometrial cancer.

AstraZeneca has announced that Imfinzi® (durvalumab) and Lynparza® (olaparib) combination has been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP) for certain patients with primary advanced or recurrent endometrial cancer. 

New and expanded Pharmaceutical Benefits Scheme (PBS) listings are to be implemented in Australia for AstraZeneca/MSD’s Lynparza® (olaparib), expanded for use for patients with human epidermal growth factor receptor 2 negative (HER2-negative) high-risk early breast cancer with specific gene mutations, and AstraZeneca’s Saphnelo® (anifrolumab), listed for the first time to treat the severe systemic form of lupus erythematosus (SLE) in patients with high disease activity despite standard treatment. 

A paper published in Nature Communications on 5 March 2024 regarding a Phase II clinical trial sponsored by Arcagy-GINECO showed that FKB238 (bevacizumab biosimilar) + olaparib + durvalumab combination showed better survival for treatment of patients with relapsed ovarian cancer than patients with no treatment.  Between 1 March 2019 and 23 January 20202, a total of 74 patients were enrolled in nine French centres and were treated with the bevacizumab biosimilar FKB238 (15 mg/kg intravenously, once-every-3-weeks), olaparib (300 mg orally, twice daily), and durvalumab (1.12 g intravenously, once-every-3-weeks).  

The National Institute for Health and Care Excellence (NICE) issued final draft guidance recommending AstraZeneca/MSD’s Lynparza® (olaparib) with bevacizumab be routinely used in the NHS in England and Wales for maintenance treatment of high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose cancer has completely or partially responded after first-line platinum-based chemotherapy with bevacizumab, is advanced (stages 3 and 4) and is HRD positive (BRCA1 or BRCA2 mutation or genomic instability).

On 24 August 2023, AstraZeneca announced the Japanese MHLW expanded the approval for Lynparza® with abiraterone to treat BRCAm mCRPC.