Five treatments approved and three terminated as NICE issues August decisions

The National Institute for Health and Care Excellence (NICE) has issued nine Technology Appraisal decisions in August 2026, comprising five positive first recommendations, one updated positive recommendation, and three terminations. Decisions were issued between 5 and 26 August 2026 and span cardiology, haematological oncology, immunology, respiratory medicine, and allergy. The August cycle is notable for two new combination regimens in blood cancers, a first-in-class oral therapy for hereditary angio-oedema, and the approval of a sublingual immunotherapy tablet for dust mite allergy — a relatively novel route of administration in this therapeutic area.

Three terminated appraisals in a single month is an unusually high number, and includes the CAR-T cell therapy Breyanzi in follicular lymphoma, a setting in which the treatment had previously received a positive recommendation in diffuse large B-cell lymphoma.

 

Positive Recommendations

Kerendia recommended for heart failure

Finerenone (Kerendia), a non-steroidal mineralocorticoid receptor antagonist developed by Bayer HealthCare, received a positive NICE recommendation on 5 August 2026 for heart failure. Finerenone is already approved in the EU and UK for chronic kidney disease associated with type 2 diabetes, and this recommendation extends its application to heart failure, a condition in which fluid overload and neurohormonal activation play a central role in disease progression. Unlike older steroidal mineralocorticoid receptor antagonists such as spironolactone and eplerenone, finerenone has been designed to offer greater receptor selectivity, potentially reducing the risk of hyperkalaemia and other off-target effects while maintaining cardiovascular and renal protection.

Dawnzera recommended for hereditary angio-oedema

Donidalorsen (Dawnzera), an oral plasma kallikrein inhibitor developed by Ionis Pharmaceuticals and Otsuka, received a positive NICE recommendation on 19 August 2026 for the prevention of attacks in hereditary angio-oedema (HAE). HAE is a rare and potentially life-threatening genetic condition characterised by episodes of severe swelling affecting the skin, gastrointestinal tract, and upper airways; laryngeal attacks in particular can be fatal without prompt treatment. Donidalorsen is administered orally on a prophylactic basis, offering a significant practical advantage over existing parenteral prophylactic therapies. The recommendation represents a meaningful step forward for patients seeking a convenient, long-term preventive option.

Calquence combinations recommended for mantle cell lymphoma and CLL

Two separate NICE recommendations were issued on 19 August 2026 for acalabrutinib (Calquence)-based combination regimens in haematological malignancies, both submitted by AstraZeneca.

For mantle cell lymphoma, acalabrutinib in combination with bendamustine and rituximab (Calquence, Treanda, and Rituxan) was recommended for previously untreated patients. Mantle cell lymphoma is an aggressive B-cell non-Hodgkin lymphoma with a tendency to relapse; adding BTK inhibition to the established bendamustine-rituximab backbone offers a chemotherapy-intensified and targeted approach that has demonstrated improved outcomes in clinical trials.

For chronic lymphocytic leukaemia and small lymphocytic lymphoma (CLL/SLL), acalabrutinib in combination with venetoclax, with or without obinutuzumab (Calquence, Venclexta, and optionally Gazyva), was recommended. This all-oral, chemotherapy-free triplet targets three distinct mechanisms: BTK inhibition, BCL-2 inhibition, and CD20 targeting. CLL is the most common adult leukaemia in the Western world, and the combination approach represents a shift towards deeper, potentially time-limited treatment that may reduce the likelihood of resistance compared with continuous monotherapy.

Odactra recommended for dust mite allergic rhinitis

The sublingual allergy immunotherapy tablet for house dust mite allergy (Odactra), developed by ALK-Abello, received a positive NICE recommendation on 26 August 2026 for allergic rhinitis caused by house dust mite sensitisation. Allergen immunotherapy is the only treatment modality that addresses the underlying allergic mechanism rather than simply controlling symptoms, and sublingual tablet formulations offer a more convenient alternative to subcutaneous immunotherapy injections administered in a clinical setting. The recommendation is significant for the large number of patients with persistent, poorly controlled dust mite allergic rhinitis who do not achieve adequate symptom relief with antihistamines and intranasal corticosteroids.

 

Updated Recommendation

Itulazax receives updated recommendation for birch pollen allergy

Betula verrucosa sublingual tablet (Itulazax), a birch pollen allergen immunotherapy developed by ALK-Abello and partnered with Torii Pharma and Shionogi, received a positive second appraisal recommendation on 25 August 2026 for allergic rhinoconjunctivitis caused by birch pollen. Itulazax is administered daily as a sublingual tablet and works by gradually desensitising the immune system to birch pollen allergens over a course of treatment typically lasting several years. The updated recommendation follows the initial positive appraisal and likely reflects revised evidence or access arrangements, and sits alongside the same cycle’s first recommendation for Odactra, underscoring growing NICE support for sublingual immunotherapy as a treatment modality across different allergen types.

 

Terminated Appraisals

Brinsupri appraisal terminated for non-CF bronchiectasis

The appraisal of brensocatib (Brinsupri), a dipeptidyl peptidase 1 (DPP1) inhibitor developed by Insmed, was terminated on 25 August 2026 for non-cystic fibrosis bronchiectasis. Bronchiectasis is a chronic lung condition characterised by irreversible airway dilation and recurrent infections driven by neutrophilic inflammation; DPP1 inhibition reduces the activation of neutrophil serine proteases that contribute to lung damage and exacerbations. Brensocatib had been considered a significant advance in a condition with very few approved pharmacological therapies, making its termination a notable setback for patients and clinicians in this field. The reasons for termination were not specified in the available data.

Wayrilz appraisal terminated for immune thrombocytopenic purpura

The appraisal of rilzabrutinib (Wayrilz), an oral BTK inhibitor developed by Principia Biopharma and Sanofi, was terminated on 20 August 2026 for immune thrombocytopenic purpura (ITP). ITP is an autoimmune bleeding disorder characterised by low platelet counts resulting from immune-mediated destruction of platelets and suppression of platelet production. Rilzabrutinib targets the B-cell receptor signalling pathway and had been under investigation as an oral option for patients with persistent or chronic ITP who have failed or are intolerant of existing therapies. The termination means this treatment will not be available via the NICE appraisal route at this time.

Breyanzi appraisal terminated for follicular lymphoma

The appraisal of lisocabtagene maraleucel (Breyanzi), a CD19-directed CAR-T cell therapy developed by Bristol Myers Squibb, was terminated on 20 August 2026 for relapsed or refractory follicular lymphoma. This termination is particularly notable given that Breyanzi received a positive NICE recommendation for diffuse large B-cell lymphoma earlier in 2026, and is approved in other markets for follicular lymphoma. Follicular lymphoma is an indolent B-cell malignancy that, despite its relatively slow progression, frequently relapses and ultimately requires multiple lines of therapy. CAR-T cell treatment has shown strong efficacy in this setting, and the termination — likely reflecting cost-effectiveness or access agreement issues — will be disappointing for patients and their clinicians.

Decisions referenced carry NICE Positive 1, NICE Positive 2, or Terminated status, issued between 5–26 August 2026. This article is based on data from the NICE Technology Appraisal Programme for England and Wales.